DfR Solutions in College Park MD is looking for Part Time Quality Manager (QM). The function of the QM is to ensure that processes needed for the ISO 9001 – 2008 Quality Management System (QMS) are implemented and maintained. The QM reports to top management on the performance of the QMS and identifies any need for improvement. Additional functions include the promotion of awareness of customer quality requirements throughout the organization, to liaise with the external assessment body on all matters related to the external accreditation process, to ensure calibration of equipment is maintained, and to act as the facility security officer.

Reporting Relationship(s)

The QM is selected by and reports to the CEO.

General

To perform this job successfully, an individual must be able to complete all areas outlined for this position in a satisfactory manner. Listed below are representative of the knowledge, skills, and/or abilities necessary to meet the minimum job requirements. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

Required: College degree in engineering with a major in electrical, mechanical or computer science.

Experience

Required: Ten years experience in quality management, with a minimum six years experience in ISO 9001. Experience working on Secret level or above on DoD programs.

Skills, Knowledge and Abilities

Ability to manage corrective and preventive actions, process improvement, and conduct internal audits. Must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.

Ability to understand, comply, and improve established company policies and procedures. Must have technical writing skills to develop policies, procedures, work instructions. Must be able effectively use Microsoft Office software (e.g., Word, Excel, Power Point, Access)

Business process communications are a part of the job and the QM must have the skills to ask questions, collect business process information, and working with others in a positive and collaborative manner. Business processes include, marketing and sales, purchasing, human resources, accounting and financial processes and the ability of speaking effectively and communicating directly with all levels of personnel is required.

Authority

The QM (Compliance Manager) is selected by the CEO and is delegated the authority to accomplish the duties and responsibilities of the position including, but not limited to:

Management of quality policies, procedures, processes, programs, and practices, to assure the company of continuous improvement, conformance and effectiveness.

Responsibility for the ISO Quality Management System (QMS) and all of its related compliance.

Facility security officer (Must be able to maintain a DoD clearance – ideally the applicant will have an active clearance within the last two years)

Duties and Responsibilities

Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS.

Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.

Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS.

Ensure that Quality Objectives are set by the CEO for measuring the performance of the QMS and that these are regularly reviewed.

Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.

Ensure that all suppliers used by the organization are selected, evaluated and re-evaluated and that records of this assessment are maintained.

Ensure that top management undertakes periodic but regular assessments of customer satisfaction and that consequent improvement are identified and implemented.

Ensure that an internal audit program is adopted to verify that the QMS conforms to ISO 9001 – 2008 and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case. Ability to conduct internal ISO audits (the ideal candidate will be a certified auditor)

Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed.

Manage security clearances and provide security training to both cleared and uncleared staff

Perform FSO duties including handling security tasks in office, making badges, and controlling access to office.

Perform e-QIP investigations on new security clearances. Activate and de-activate security clearances

Ensure that DfR Solutions retains a facility clearance and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case.

Please send resumes to:

Director, Software Quality

Position Summary

Responsible for establishing and implementing software Quality Assurance processes and procedures for product and non-product software using guidance from US and international guidance and standards.

Responsibilities

• Development and maintenance of software Quality Assurance procedures

• Product and non-product software Quality Assurance including software development lifecycle and validation.

• Support new product submissions for products containing software.

• Review and/or perform software validations including:

o prepare protocols

o review and approve protocols from other authors

• Assist in design, development and maintenance of a Quality System compliant with cGMPs and ISO and other International regulations.

Position Requirements

• BS or MS degree in technical/scientific/engineering discipline

• Minimum of 8 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or a related industry.

• Experience working with the FDA and/or ISO auditors required.

• Experience with new product submissions for products containing software required.

• ASQ certification (CQE, CRE, CQA) is preferred.

• Excellent working knowledge and experience of FDA’s Quality System requirements (QSR),ISO 9001 and ISO13485:2003 standard.

• QA experience in software is a plus.

• Ability to coordinate multiple projects.

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

www.mesoscale.com

Product Quality Engineer

Position Summary

Responsible for the design, implementation and management of design & development programs, from concept through product release in an ISO 13485:2003 and FDA (QSR) environment. This will include training the appropriate personnel on company design & development processes and procedures.

Responsibilities

Assist in creating design & development program quality plans, including program phase activities, tasks, schedules, timelines and documentation checklists.

Project Phase Management

” Complete quality planning and execution for each phase of design & development programs

o Complete all documentation for each design & development program reviewed, approved and archived

o Guide and direct required activities during each phase of the design & development program(s)

o Ensure final product(s) comply with all appropriate quality and regulatory requirements

Internal Audits

” Act as QA representative of the company’s design & development programs activities and documentation for all internal and external audits

o Follow-up on design control corrective action responses

” Implement appropriate problem resolution methods and verify effectiveness

Position Requirements

” Bachelor’s degree in science, engineering or related field

” Minimum 5 years relevant experience in process planning, design and development in medical devices, in vitro diagnostics, pharmaceutical or related industry

” Experience working with FDA Quality System requirements (QSR), ISO 9001 and ISO 13485:2003

” ASQ certification (CQE, CRE, CQA) preferred

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

www.mesoscale.com

Quality Engineer

Job Description: Looking for a Quality Engineer with 3-5 years of Quality Engineering experience in biomedical industry preferably in medical device industry.

Required Qualifications: BS in Scientific discipline (Chemistry, Biology, Physics, Bio Medical Engineering/ Chemical Engineering).

Preferred Qualifications: Candidates with Master’s degree, CQE, CQA, Six Sigma Black/ green belt is highly desired.

Desired Experience: Experience in FDA regulated Medical device design, manufacturing monitoring and control, experience in FDA QSR 21 CFR Part 820, cGMP, EC markings, Canadian Medical Device Standards & ISO 13485, ISO14971 Standards. Experience in applying statistical methods for quality improvements. Supplier Quality engineering and management, experience in design control and process validation, root cause analysis, Corrective and preventive action (CAPA). Experience in using Microsoft office excel, power point, word, access, project data base.

Immigration Status: US citizen or US Green Card holder.

Please contact: Eileen Smith at

Employee Type : Full-Time

Industry type : Contract Manufacturing

Industries Served : Defense, Aerospace, Mainframe Computing, Medical, Telecommunications & Transportation

Major Customers : IBM, L3 Communications, Lockheed Martin, GE Aerospace, Northrop Grumman, UFC Aerospace, Raytheon, Harris, Jabil & Liebert

Manages Others : Yes

Description

A leader in the manufacture of precision machined and fabricated metal products is seeking an experienced Quality Assurance Manager for its Baltimore facility. Reporting directly to the General Manager the Quality Manager is responsible for all quality related functions, capturing and reporting on quality metrics and serves as the Management Representative for ISO9001 and AS9100. This is a hands on position and includes inspection of product along with management responsibilities of training and supervision of department staff.

We are an ISO 9001:2008 / AS9100 Rev C Company with a 60 year history of business with Fortune 500 Customers. Our company has maintained an excellent growth record through the years and continues to aggressively seek new business opportunities. We offer a competitive salary and excellent benefits that includes vacation, medical, life and disability insurance as well as a 401K and a weekly performance based bonus.

For more information on our company and the services that we provide, visit our web site at www.raymachine.com

Preferred Experience

Mechanical Component Inspection

ISO9001 and/or AS9100 quality systems

Statistical inspection methods

DCC CMM programming

Interested parties should contact Dan Solomon @

JOB TITLE: Quality Certification Associate – Setting the Standard

As our Quality Certification Associate you will be instrumental in ensuring that some of the largest companies around the world are using the highest standards for oil and gas manufacturing practices. You will review and assess clients’ conformance in areas of environmental quality, occupational and health, and ISO 9001. You will ensure quality assurance by a thorough and independent review of audits allowing companies the use of the premier industry standard symbol that demonstrates products were produced under the requirements of our Quality Registration Program and API’s applicable specifications. Working for one of the largest and most influential trade associations in the US, you will enjoy working as a pivotal team member in a collegial, team oriented atmosphere. Come work in a professional office environment where you can enjoy technical challenges in a service related position. The salary range for this position is $63,000 – $83,000 depending on experience.

Your day to day activities will include:

• Reviewing client Quality Manuals to various quality system requirements. Working independently with national and international clients, you’ll work directly with them to solve non-compliance issues.
• Reviewing audit reports, client’s corrective action responses to non-conformances and changes (scope) to client’s registration(s) and/or license(s).
• Making recommendations for granting, maintaining, modifying, suspending or cancelling registrations/licenses and changes (scope) based on the result of the review.
• Preparing action letters for granting, maintaining, modifying, suspending or cancelling registrations/licenses.
• Working with your peers to review program actions completed by your team members.
• Interacting directly with clients and auditors on issues related to program activities.
• Assisting the Audit Program staff in the management of auditor’s activities.

If you are our ideal candidate your background and experience would include:

• Bachelors degree in business or technical discipline
• A minimum of 2-4 years of industry experience, in any combination; with quality systems; with applicable manufacturing; or within the petroleum industry.
• Strong understanding of ISO 9001, ISO 14000 and other quality specifications requirements.
• Experience / knowledge of ISO-14001, OHSAS 18001 and other management system standards a plus.
• Successful completion of the ISO 9000 Lead Auditor Training Course.
• Ability to research and assimilate information accurately from a variety of sources desired.
• Expert understanding of Microsoft applications especially Word, Excel, Access and SharePoint with an aptitude to learn other computer programs quickly.
• Attention to detail, exceptional organization and prioritization skills required.
• Customer service aptitude required.

To apply directly go to http://www.api.org/aboutapi/jobs/

The American Petroleum Institute (API) is the only national trade association that represents all aspects of America’s oil and natural gas industry. Our nearly 400 corporate members, from the largest major oil company to the smallest of independents, come from all segments of the industry. They are producers, refiners, suppliers, pipeline operators and marine transporters, as well as service and supply companies that support all segments of the industry. We offer excellent benefits, competitive salary and a great working atmosphere. Visit us at www.api.org

QA Manager III 208481 (NCI) Job

Location: Rockville, MD, US
QA Manager III 208481 (NCI) Full Time Regular posted 9/6/2011

Job Category: CTR – Clinical/Regulatory
Req ID: 208481
Able to obtain security clearance? None
Currently possess security clearance? None
Location: Rockville, MD
% Travel:
Relocation: Yes

Requirements: THIS POSITION IS FUNDED BY AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDING.

PROGRAM DESCRIPTION

The Cancer Human Biobank (caHUB) program managed by the NCI Office of Biospecimen and Biorepository Research (OBBR) is developing a set of research and biobanking projects that are determining the link between biospecimen quality and research variables.

JOB DESCRIPTION

The Quality Manager will work within a SAIC-F team partnering with staff in the OBBR and caHUB programs. The caHUB program is committed to consistently deliver the highest quality biospecimens and data and strives to continually improve services and systems to meet the needs of the research community. SAIC-F is the prime contractor for this effort and is providing management and technical support for OBBR programs. The Quality Manager will implement and oversee internal caHUB processes and provide quality oversight to SAIC-F subcontracts and partners supporting OBBR and caHUB programs. Oversee the management of the Quality Management System currently in place for OBBR and caHUB. Identify the requirements of the Quality Management plan and disseminate the information to the caHUB Executive Management. Approve and evaluate the quality management processes of SAIC-F subcontractors and assist Executive Management as necessary in the definition of additional processes and SOPs as appropriate to overall program execution quality, including: 1)Develop plans for new (and revising existing) SOPs; In particular, add JIRA activities for checklists and processes that need to be developed; 2) Manage control of Document Control Order (DCO) processes, caHUB SOPs in development, contract SOPs in review and other DCO items that require control; 3) Manage Corrective and Preventive Action (CAPA) activities; 4) Manage Contractor Corrective Action Report (CCAR) activities; 5) Manage complaint log activities; 6) Manage Nonconformance Report (NCR) activities; 7) Manage qualification activities; and Manage validation activities.

REQUIRED SKILLS:

* Possession of a Bachelor’s degree from an accredited college/university in a field related to biomedical research or four (4) years related experience in lieu of degree.
* Master’s degree preferred.
* Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States.
* In addition to education requirements, a minimum of eight (8) years of progressively responsible experience in Quality Management including two (2) years of experience in a management capacity.
* Must have relevant biospecimen and repository experience.
* Ability to communicate clearly with all levels of clinical and scientific personnel and administrative staff through written and oral presentations.
* Demonstrated success in previous management positions and show evidence of both independent thought and leadership and have experience in working in a highly integrated, multi-disciplinary environment.
* This position is subject to obtaining a Public Trust Clearance.

DESIRED SKILLS:

* Experience in 1) quality management of biospecimen laboratory source site acquisition, 2) managing the development and deployment of quality management processes that are subject to regulatory requirements in the quality tracking of biospecimen resources, including those that are subject to 21 CFR Part 11, HIPAA, FISMA, Section 508 of the Rehabilitation Act, and OMB Memorandum M-06-16.

SAIC-Frederick Inc., a wholly owned subsidiary of SAIC, is accelerating the development of new technologies and treatments for patients with cancer and AIDS. SAIC-Frederick is the operations and technical support contractor for the National Cancer Institute at Frederick, a federal national laboratory. -LI

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Nearest Major Market: Washington DC
Job Segments: Administrative, CAPA, Document Control, Laboratory, Law, Legal, Management, Manager, QA, Quality, Quality Assurance, Quality Manager, Research, Science, Technical Support, Technology

http://jobs.saic.com/job/Rockville-QA-Manager-III-208481-%28NCI%29-Job-MD-20847/1438323/

QA Engineering Inspector Job

Location: Aber Prov Grd, MD, US
QA Engineering Inspector Full Time Regular posted 11/9/2011

Job Category: MIS – Info Tech / Telecommunications
Req ID: 212772
Able to obtain security clearance? Secret
Currently possess security clearance? None
Location: Aber Prov Grd, MD
% Travel:
Relocation: No

Requirements: SAIC‘s Defense and Homeland Solutions (D&HS) Operation is seeking a Quality Assurance Engineering Inspector to support a major DoD prototype program to include engineering design, manufacturing, system assembly and installation, test and evaluation, logistics, fielding and sustainment.

This position will have responsbilities to Provide quality, configuration management, change management support and performance assessment support to rapid prototype production facilities located on Aberdeen Proving Ground, MD. This is a hands on position located in a manufacturing facility where candidate will use their engineering and product knowledge to compare design plans and materials to specifications and drawings to ensure the components manufactured meet the drawing tolerances. Will have ownership for Establishment, implementation and accociated documentation of oversight programs including performance assessment, performance surveillance, document review, and non conformance and compliance tracking processes. Facilitation of a Configuration Control Board for managing design changes. Perform assessments of Subcontractor activities to ensure compliance with program requirements; provide expertise in the evaluation of engineering change proposals, procedures, requests for information and other internal documentation.

Required Education/Experience: Bachelor’s degree in a related technical field and 5-7+ years related Quality Control or Continuous Process Improvement experience; or 10+ years related experience in lieu of bachelor’s degree. Successful candidate will have at least 5 years experience in Prototyping, manufacturing or Product development environment.

Required Skills: Excellent communication and presentation skills. Strong technical writing skills. Previous product development experience is preferred.

All candidates must be US Citizens due to federal contract requirements and be able to obtain and maintain a secret security clearance.

SAIC is a FORTUNE 500® scientific, engineering, and technology applications company that uses its deep domain knowledge to solve problems of vital importance to the nation and the world, in national security, energy and the environment, critical infrastructure, and health. For more information, visit www.saic.com. SAIC: From Science to Solutions®

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Job Segments: Business Process, Change Management, Defense, DoD, Engineer, Engineering, Facilities, Government, Inspection, Inspector, Management, Operations, Product Development, QA, QA Engineer, QC, Quality, Quality Assurance, Quality Control Inspector, Research, Technical Writer, Technology, Telecom, Telecommunications

http://jobs.saic.com/job/Aber-Prov-Grd-QA-Engineering-Inspector-Job-MD/1524687/

Quality Manager Job

Location: MD, United States

Job Number: 1449822

Business GE Transportation

Business Segment: Transportation

About Us: GE is planning for tomorrow. Where will you be? For more than 125 years, GE has been respected for its performance and innovative spirit. GE people worldwide are dedicated to turning imaginative ideas into leading products and services that help solve some of the world’s toughest problems. Working for GE Transportation is exciting & challenging. Come see what you are missing!

Posted Position Title: Quality Manager

Career Level: Experienced

Function Quality

Function Segment: Lean Six Sigma

Location: United States

U.S. State, China or Canada Provinces: Maryland

Relocation Assistance Yes

Role Summary/Purpose: The Quality Manager develops practical and innovative ways to identify and meet goals. In this role you will be responsible for work that is less defined in scope and has the understanding and experience to execute business objectives. This role has the ability to effect short-term and some long-term business goals.

Essential Responsibilities – Provide overall Lean Six Sigma leadership for assigned business unit

- Provide leadership and direction to Black Belts and lean resources in executing the Lean Six Sigma strategy for breakthrough levels of improvement in customer satisfaction, process capability and quality

- Work with quality champion(s) and other operating leaders to develop project deployment strategy, goals and priorities

- Serve as change agent by stimulating, communicating and institutionalizing Lean Six Sigma initiatives

- Improve customer satisfaction and reduce process variation through application of Lean Six Sigma tools and tactics

- Develop strategy and deploy Lean Six Sigma tools and tactics

- Communicate progress, status and issues to Champions and business leaders

- Seek, share and institutionalize best practices

Qualifications/Requirements: – Bachelor’s Degree from an accredited university or college OR a High School Diploma / GED with at least 4 years of experience in a manufacturing or office environment

- At least 3 years of experience in a functional area that is supported by a Six Sigma or quality position

Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Desired Characteristics

- Change agent with strong credibility and influence in the organization

- Demonstrated ability to motivate others and achieve results

- Strong analytical and quantitative skills; statistically literate and familiar with Six Sigma quality concepts and tools

- Demonstrated commitment for process improvement

- Customer-focused in defining quality and establishing priorities

- Strong oral and written communication skills

- Strong interpersonal and leadership skills

- Executive level presentation skills

Why join one great company when you can join many? We are more than 280,000 people with jobs that range from biochemist to finance specialist to wind energy engineer. We’re passionate about making life better with new ideas and technologies. We’re diverse, supporting our communities in more than 140 countries. Experience personal growth and competency development as part of the GE team. Around the world, we are helping build the healthcare, transportation and aviation of the new century.

GE Transportation is a global technology leader and supplier to the railroad, marine, drilling, wind and mining industries. We provide freight & passenger locomotives, railway signaling and communications systems, information technology solutions, marine engines, motorized drive systems for mining trucks and drills, high-quality replacement parts and value added services. With sales in excess of $4.5 billion, GE Transportation is headquartered in Erie, PA, and employs approximately 10,000 employees worldwide. Learn more about GE Transportation today!

To stay connected with exciting news and the latest job opportunities from Aviation, Energy and Transportation, follow us on twitter: @geconnections

Job Segments: Aviation, Biochemistry, Business Process, Energy, Lean Six Sigma, Management, Manager, Marketing, Quality, Quality Manager, Science, Six Sigma, Social Media, Wind Energy

http://jobs.gecareers.com/job/Quality-Manager-Job-MD/1488020/

Quality Engineer (Ref: QAE1)
Job Title:     Quality Engineer
Department:     Corporate
Location:     Lanham, MD

Quality Assurance Analyst, Technical Writing (Ref: QATWHSV1)
Job Title:     Quality Assurance Analyst, Technical Writing
Department:     Quality Assurance Department
Location:     Huntsville, MD

http://www.ai-solutions.com/Careers/Applyforajob/Overview.aspx

QM Senior New Product EngineerFull-time
US-Maryland, US-Maryland-Baltimore
Requisition ID QUA100QE

QM Senior EngineerFull-time
US-Maryland-Baltimore
Requisition ID QUA100II

QC Inspector IIIFull-time
US-Maryland-Baltimore
Requisition ID QUA100M7

Director, Quality and Regulatory Compliance Full-time
US-Maryland-Baltimore
Requisition ID QUA100Q8

Continuous Improvement Mechanical Engineer – Manufacturing Full-time
US-Maryland-Baltimore
Requisition ID MAN101SJ

http://www.bd.com/us/careers/jobs.asp

Quality Engineer

Job Title: Quality Engineer

Job Type: Full-Time

Location: Baltimore, MD

Job Description:

JOB TITLE: Quality Engineer

DEPARTMENT: Assembly Centers Quality Assurance

Summary of Responsibilities:

Develops and implements quality assurance standards, processes and controls. Develops methods for inspection, testing sampling, and training. Evaluates production capabilities and recommends improvements. Provides quality assurance support to ensure that the products produced are manufactured in accordance to the specifications and requirements as defined by the customer and/or company. Respond to customer identified issues and assist in maintaining the Quality Management System.

Essential Functions / Responsibilities:

•Quality Improvement Teams: Organizes and facilitates the Quality Improvement Team Meetings in their respective areas. Maintains action register and charts for the meetings.

•Product & Process Audits: Performs required audits by completing necessary inspection procedures (product operation, certification and test procedures), using the appropriate documentation, and attesting to the quality of the product prior to shipment.

•Quality Documentation: Develop control plans for all processes and train employees in control plans. Write and maintain quality manual.

•Quality Requirements: Ensures and verifies accuracy and completeness of quality requirements, inspection sheets, engineering documents and sampling sheets used when inspecting parts or units.

•Quality Measurements: Uses basic precision measuring tools, workmanship standards, visual inspection and referencing specifications and blueprints to identify discrepancies. May include calibration activities.

•Document Deficiencies: Document deficiencies identified that do not meet the specifications and requirements. Provide a means to track and address repetitive issues with internal and external suppliers. Follow up with corrective action.

•Troubleshooting/Problem Solving: Troubleshoots daily issues and determines the root cause of the problem. Initiates proper Problem Solving: procedures in order to resolve the problem. Involves the appropriate departments.

•Pilot Runs: Assist Manufacturing and Design Engineering during pilot run’s of prototype units to determine undocumented quality requirements and/or test procedures that should be added to the Quality Requirements.

•Interact with Service: Works with the Service Department to exchange quality information necessary to promote continuous improvement.

•Communications: Communicate in the appropriate manner with the appropriate formats (i.e. documents, email, charts, etc.) as necessary to convey quality information to the required parties.

•Change Request (CR): Participate and make recommendations for continuous improvement by submitting CR’s.

•Deviations: Initiates deviations for individual parts, assemblies or machines when it is applicable.

•Non-conformities: Initiate by completing the information required on the appropriate form pertinent to the (Red Tag’s & Rework Sheets) issue identified.

•Corrective / Preventative Actions (CA): Initiate Corrective/Preventative Action notices as determined necessary to ensure quality processes and products.

•Machine Change Orders (MCO): Reviews the MCO database to ensure that products are in compliance.

•Meetings: Participates in meetings as required. Completes follow-up activities in a timely manner.

•Training – Resource: Provides training to the appropriate people as required on product operation and/or important information that has been identified that requires a “need-to-know” status.

•Continuous Improvement /Special Projects: Assist and participate when required and approved by the Quality Manager.

QUALIFICATIONS:

Required Education/Certifications:

•Applicants must have one of the educational backgrounds to apply:

•CQE Certificate (Certified Quality Engineer)

•PE Certificate (Professional Engineer)

•Four-year college degree in Mechanical Engineering, Industrial Technology

•AWS Certifications

 •Quality Tools & Techniques: Effectively uses quality tools and techniques to assist in determining compliance to specifications, trends, capabilities, and opportunities for continuous improvement.

•Blueprint Reading: Ability to read and interpret blueprints applicable to the process.

•Computer Knowledge: Must be knowledgeable of computer systems and pertinent software.

•PC – IBM Format

•MS Outlook, Word, Excel, Access, Project, PowerPoint.

•SPC Software

Desired knowledge of the following systems and pertinent software:

•AS/400, Mapics, Pro-E

•Access Required Documents: Ability to learn and access the required documents necessary to perform job function.

•Precision Measuring Equipment: Ability to demonstrate effective use of precision measuring tools and/or equipment.

•Working Conditions: Fairly light physical activity generally associated with an office environment. Will be exposed to noise and dust while in the production and test areas thus requiring the appropriate safety equipment such as safety glasses, ear plugs and other protective equipment as necessary.

Experience:

•Required Experience: 3-5 years relevant experience in manufacturing and production processes. Prefer experience in the automotive or agricultural equipment manufacturing industries.

•Supervisory Experience: Quality Engineers may have Quality Technicians reporting to them directly. Associated Supervisory experience, skills and responsibility is preferred and may be required.

•Must have Geometric Dimensioning and Tolerancing experience

Required Skills:

•Team Player/Teamwork: Must possess good interpersonal skills. Demonstrates the ability to work with others efficiently and effectively either one-on-one, as a team, or in a group.

•Personality: Must posses a positive attitude with self-motivation.

•Communication: Must be able to communicate effectively with good verbal and writing skills.

•Problem Solving: Ability to utilize problem solving skills and techniques to achieve problem resolution. Problem solving skills may include experience with:

•Six Sigma

•Lean Manufacturing / Kaizen Events

•Problem Solving Disciplines (5D, 6D, 7D, 8D)

Special Job Dimensions:

•Ability to work in a Manufacturing environment as well as Office environment.

•Working Conditions: Fairly light physical activity generally associated with an office environment. Will be exposed to noise and dust while in the production and test areas thus requiring the appropriate safety equipment such as safety glasses, ear plugs and other protective equipment as necessary.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

http://www.agcocorp.com/north_american_job_search.aspx

Six Sigma Master Blackbelt Job

Date: Oct 18, 2011

Location: Aberdeen, MD, US

Six Sigma Master Blackbelt-01113228

Description

Key Role:

Serve as part of a team that develops Six Sigma consulting methods and ensures the appropriate methodology design and deployment of six sigma tools and techniques, including the execution of Six Sigma projects. Design and develop Lean and Six Sigma training and delivery. Support clients with the implementation of Six Sigma and Lean methodologies to improve business processes. Coach clients with the use of analytical tools associated with Six Sigma applications. Guide client organizations in managing changes related to the implementation and use of the Six Sigma approach. Apply program management techniques to ensure the on-time, high-quality delivery of products. Manage projects and ensure their compliance. This position is located in Aberdeen, MD.

Qualifications

Basic Qualifications:

-5+ years of experience as a Certified Six Sigma Black Belt or Master Black Belt

-Experience with leading, delivering, and marketing transformation, change management, and continuous process improvement

-Experience with building and maintaining client relationships in a team-based government or management consulting environment

-Experience with managing project teams, including direct responsibility for people development

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-Experience with Microsoft Office, including Excel and PowerPoint

-Knowledge of the DoD and Army environment is preferred

-Possession of excellent presentation skills and “executive presence”

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

Integrating the full range of consulting capabilities, Booz Allen is the one firm that helps clients solve their toughest problems, working by their side to help them achieve their missions. Booz Allen is committed to delivering results that endure.

We are proud of our diverse environment, EOE, M/F/D/V.

Job: Change Management

Primary Location: United States-Maryland-Aberdeen

Nearest Major Market: Baltimore

Job Segments: Business Process, Change Management, Consulting, Defense, DoD, Government, Lean Six Sigma, Management, Management Consulting, Military, Program Manager, Security Clearance, Six Sigma, Six Sigma Black Belt, Technology

http://careers.boozallen.com/job/Aberdeen-Six-Sigma-Master-Blackbelt-Job-MD-21001/1496672/

Job Title: Quality Assurance Specialist (Mechanical)

Department: Department of Defense

Agency: Defense Contract Management Agency

Job Announcement Number: SWH811P6440334D (http://www.usajobs.gov/GetJob/ViewDetails/302217200)

SALARY RANGE: $62,467.00 to $81,204.00 / Per Year

OPEN PERIOD: Wednesday, November 02, 2011 to Monday, November 14, 2011

SERIES & GRADE: GS-1910-11

POSITION INFORMATION: – - This is a Permanent position. — Full Time

DUTY LOCATIONS: 1 vacancy(s) in the following locations:

MD – Frederick County

WHO MAY BE CONSIDERED: US Citizens

JOB SUMMARY:

Join Team DCMA — Challenge yourself!

The Defense Contract Management Agency is a rich resource of indispensable partners who contribute to

and benefit from integrated missions and programs. We are an independent combat support agency

within the Department of Defense (DoD). We are the Department’s contract manager, responsible for

ensuring Federal acquisition programs, supplies, and services are delivered on time, within cost and

meet performance requirements.

Reviews contracts and technical data packages to identify specification requirements which contractor’s

processes must meet; validates contractor has processes for properly extracting and translating these

requirements into appropriate inspection, test, engineering, production, manufacturing,

packaging/marketing, shipping, purchasing, and receiving…

About the Position: Join the DCMA Team; it offers a world of opportunity! DCMA works directly with

Defense suppliers to help ensure that DoD, Federal, and allied government supplies and services are

delivered on time, at projected cost, and meet all performance requirements. DCMA directly contributes

to the military readiness of the United States and its allies, and helps preserve the nation’s freedom.

DCMA has civilian, active duty and reserve personnel working in offices located worldwide. Federal

Government employment offers salary increases (http://www.opm.gov/oca/11tables/index.asp), full

health and life insurance, retirement savings, and other benefits (Working for the Federal Government -

Benefits at http://www.usajobs.gov/EI/benefits.asp), training opportunities and valuable experience

gained in positions through mobility, reassignments (http://www.dcma.mil/careers/index.cfm) and

competitive procedures (http://www.usajobs.opm.gov/).

Organization(s):

Defense Contract Management Agency, DCMA Operations Directorate, Eastern Regional Command,

DCMA Aircraft Propulsion Operations, Duty Location:

Frederick, MD

The Senior Quality Engineer has responsibility for applying / interpreting the applicable Quality Systems, developing / implementing the Standard Operating Procedures and policies for the organization. Develops and maintains schedules and timelines regarding new product development projects / other projects. Ensures the documentation process remains compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure design control, process control, consistent supplier qualification practices for new products and identifies / recommends opportunities for continuous improvement (internal / external). Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. May support both internal and external audits.

Responsibilities on design team included in Cost Specific Responsibilities section. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making process to support predictable product design, flow and transfer. Initiates CAPAs and may lead the investigation / corrective action process.

Knowledgeable in specific automated systems as noted and engaged in new product introductions as the Core Team member representing the Quality function.

The New Product Development position is accountable to participate on new product development projects and manage Quality function deliverables.

The Senior New Product Engineer is considered the Quality subject matter expert in Design Control, and has responsibility as the Quality representative on one or more project teams engaged in new product development for Advanced Biosciences.

” Responsible for assuring that each project / product is developed and released meeting customer expectations, regulatory / industry requirements including 21CFR 820 & 210, ISO 13485, 14971 and 10993, MDD 93/42/EEC and USP clean room, testing standards and within specified time lines.

” Responsible for development planning, design input, design output, design history file management, design transfer, change management, design reviews for Quality.

” Reviews and approves product documentation, specifications, drawings, process and design verification/validation and QC testing.

” Applies statistical tools to analyze data and identify root cause and problem resolution.

Qualifications

Bachelor’s degree with 5 years experience * or MS with 3 years experience. Typical degree in Biological Sciences, Chemistry, and Engineering, Computer Science and / or Regulatory Affairs or other related field.  * in a regulated environment

” Ability and skill to effectively manage multiple tasks and drive execution of design plans.

” Ability and skill to lead or manage process control, supplier quality for new products and continuous improvement projects using statistical technique / tools such as: Statistical sampling, SPC, Six Sigma, additionally root cause analysis and project management techniques are routinely employed.

” Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience.

” Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings and formal presentations to both small and large groups.

” Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.

” Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution.

” Demonstrated workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and 210, International Organization for Standardization (ISO) ISO 9000:2000 and 13485:2003 and USP Clean Room and QC Testing standards.

” Professional certification preferred, such as: Six Sigma, ASQ, AAMI, and Good Validation practices.

” Experienced in Microsoft Office suite skills. Basic mini tab and / or related analytical software programs

Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, and IGQA auditor.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.

BD is an Equal Opportunity/Affirmative Action Employer.

To apply: please visit BD directly at http://www.bd.com/careers and select by key word QUA100QE

Position Summary

The VP of Quality Assurance and Regulatory Affairs is responsible for facilitating the direction and management of all Quality Assurance, Operations Quality and Regulatory Affairs activities for the company.

Responsibilities

Manage overall Quality System and Regulatory functions including:

1. Manage Quality Assurance

” CAPA

” Documents, Records, Change Control

” Design Control Quality

” Management Responsibility

2. Manage Quality Control staff and functions for

” Consumable operations (plate assembly and coating, reagent preparation, filling, kit assembly etc.)

” Instruments (assembly, testing shipping etc.)

” Incoming Quality Control staff and operations for Consumables and Instruments.

” Manage production, warehousing and shipping quality.

” Quality operations for material handling and storage within MSD manufacturing operations.

3. Development and maintenance of processes and procedures for the Quality System

4. Maintain compliance with all applicable regulations and standards.

Position Requirements

” Bachelor’s degree in Biology, Chemistry, Biochemistry, Organic Chemistry or Engineering is required. Master’s degree would be beneficial.

” Minimum 10 years of work experience in Quality for FDA regulated employer(s) with a thorough understanding of Quality Management principles, tools and practices

” Minimum 10 years management experience in Quality and/or Operations with a GMP company(s) that design, develop and manufacture products.

o This experience must include a minimum of 5 years medical device experience (Quality System Regulation)

” Three years recent experience in diagnostics, is strongly preferred

” Manager, Quality Organizational Excellence certification from ASQ is preferred

” ASQ (CQE, CRE, and/or CQA) are strongly preferred

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

http://www.mesoscale.com

Position Summary
The VP of Quality Assurance and Regulatory Affairs is responsible for facilitating the direction and management of all Quality Assurance, Operations Quality and Regulatory Affairs activities for the company.

Responsibilities
Manage overall Quality System and Regulatory functions including:
1.  Manage Quality Assurance
“  CAPA
“  Documents, Records, Change Control
“  Design Control Quality
“  Management Responsibility
2.  Manage Quality Control staff and functions for
“  Consumable operations (plate assembly and coating, reagent preparation, filling, kit assembly etc.)
“  Instruments (assembly, testing shipping etc.)
“  Incoming Quality Control staff and operations for Consumables and Instruments.
“  Manage production, warehousing and shipping quality.
“  Quality operations for material handling and storage within MSD manufacturing operations.
3.  Development and maintenance of processes and procedures for the Quality System
4.  Maintain compliance with all applicable regulations and standards.

Position Requirements
“  Bachelor’s degree in Biology, Chemistry, Biochemistry, Organic Chemistry or Engineering is required.  Master’s degree would be beneficial.
“  Minimum 10 years of work experience in Quality for FDA regulated employer(s) with a thorough understanding of Quality Management principles, tools and practices
“  Minimum 10 years management experience in Quality and/or Operations with a GMP company(s) that design, develop and manufacture products.
o  This experience must include a minimum of 5 years medical device experience (Quality System Regulation)
“  Three years recent experience in diagnostics, is strongly preferred
“  Manager, Quality Organizational Excellence certification from ASQ is preferred
“  ASQ (CQE, CRE, and/or CQA) are strongly preferred

Company Summary
Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.
MSD offers competitive salaries and outstanding benefits, including:
Medical (Open Access/PPO) / Prescription / Dental / Vision Plans
401(k) Plan with Company Matching Contributions
Flexible Spending Accounts for Health and Dependent Care expenses
Group Life and AD&D Insurance, Supplemental Life Insurance
Short and Long Term Disability Insurance
Paid Vacation Leave, Sick Leave, and Company Holidays
Extended Holiday Break
Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer.  The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law.  It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans.  This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law.  The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint.  This policy includes all forms of sexual harassment.

www.mesoscale.com

Quality Engineer/CAPA Coordinator

Position Summary

Provide corrective action and/or preventive action (CAPA) support to ensure delivery of the highest quality product. This position assists in review of investigations to identify primary root causes of non-conformances and assists in the identification of appropriate corrective and preventative actions resulting from process defects (scrap, nonconforming material, customer complaints).

Responsibilities

• Review CAPA system metrics, assisting with managing the timeliness and effectiveness of the CAPA process.

o Review of CAPA reports,

o Monitor timelines and effectiveness of CAPA program

o Prepare trend analysis,

o Prepare reports for company management on the state of the CAPA program.

• Review supporting investigation data and documentation for CAPA process associated with defects and non-conformances.

• Make recommendations for primary root causes and appropriate corrective/preventative actions.

• Develop Process Monitoring

• Participate in process improvement efforts.

• Perform appropriate analysis methods to enhance sustaining product design and new product development.

• Assist in creation of Quality Tools & Training Materials

Position Requirements

• Bachelor’s degree in Engineering or a scientific discipline

o Additional experience may be substituted for a Master’s degree

• Minimum 3 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry.

• Understanding of the use of Quality Engineering tools.

• Familiarity with statistical analysis tools.

• Working technical knowledge and application of quality engineering concepts, practices and procedures. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

www.mesoscale.com

Quality Engineer/MRB Coordinator

Position Summary

The Quality Engineer/MRB (Material Review Board) Coordinator manages the effectiveness and efficiency of key processes related to discrepant material processing, disposition and process/procedure deviation.

Responsibilities

• Process Management

o Manage the Non-conforming (NC) and deviation process

o Maintain accurate and up-to-date databases and logs for NC, MRB and Deviation

o Conduct regularly scheduled MRB meetings

o Ensure proper handling, quarantine and disposition of discrepant material

o Maintain and organize documentation related to MRB, non-conforming material and document/process deviations

• Development and Implementation

o Assist in development, implementation and maintenance of a Quality System compliant with cGMPs, ISO and International regulations

o Assist in project directed development and implementation of quality standards throughout the company

o Assist and support the CAPA Coordination for implementation and maintenance of the corporate CAPA system

o Serve as proxy for the CAPA Coordinator

Position Requirements

• Bachelor’s degree in a technical/scientific/engineering discipline is required

• Minimum 5 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required.

o At least 5 years of experience planning and coordinating activities related to non-conforming (NC) materials and Material Review Board processes.

o Previous experience with FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485:2003 standards is required.

• ASQ Certified (CQE) is beneficial.

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

www.mesoscale.com

Product Quality Engineer

Position Summary

Responsible for the design, implementation and management of design & development programs, from concept through product release in an ISO 13485:2003 and FDA (QSR) environment. This will include training the appropriate personnel on company design & development processes and procedures.

Responsibilities

Assist in creating design & development program quality plans, including program phase activities, tasks, schedules, timelines and documentation checklists.

Project Phase Management

• Complete quality planning and execution for each phase of design & development programs

o Complete all documentation for each design & development program reviewed, approved and archived

o Guide and direct required activities during each phase of the design & development program(s)

o Ensure final product(s) comply with all appropriate quality and regulatory requirements

Internal Audits

• Act as QA representative of the company’s design & development programs activities and documentation for all internal and external audits

o Follow-up on design control corrective action responses

- Implement appropriate problem resolution methods and verify effectiveness

Position Requirements

• Bachelor’s degree in science, engineering or related field

• Minimum 5 years relevant experience in process planning, design and development in medical devices, in vitro diagnostics, pharmaceutical or related industry

• Experience working with FDA Quality System requirements (QSR), ISO 9001 and ISO 13485:2003

• ASQ certification (CQE, CRE, CQA) preferred

Company Summary

Meso Scale Diagnostics, LLC. (MSD) is a rapidly growing company specializing in the field of multiplexed biological measurements, providing cost effective and valuable information for drug discovery, high throughput screening and proteomics research to scientists in pharmaceutical, biotechnology, government and academic research organizations. Located in Gaithersburg, Maryland, MSD develops, manufactures and markets cutting edge instruments and assay kits based on its proprietary electrochemiluminescence detection technology.

MSD offers competitive salaries and outstanding benefits, including:

Medical (Open Access/PPO) / Prescription / Dental / Vision Plans

401(k) Plan with Company Matching Contributions

Flexible Spending Accounts for Health and Dependent Care expenses

Group Life and AD&D Insurance, Supplemental Life Insurance

Short and Long Term Disability Insurance

Paid Vacation Leave, Sick Leave, and Company Holidays

Extended Holiday Break

Company Contribution to Fitness Club Membership

MSD uses E-Verify to validate the work eligibility of employees.

Meso Scale Diagnostics, LLC. (MSD) is an equal opportunity employer. The Company provides equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, sex (including pregnancy), marital status, sexual orientation, disability, national origin, veteran status, genetic information or any other protected characteristics covered by federal, state or local law. It is the policy and practice of the Company to take affirmative action to hire and advance in employment qualified disabled individuals, disabled, recently separated, other protected, and Armed Forces service medal veterans. This policy applies to terms and conditions of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.

The Company prohibits employee harassment based on race, color, religion, ethnicity, gender (including pregnancy), gender preference and/or presentation; national origin, age, disability, genetics or any other status/group protected by federal, state or local law. The Company also prohibits any form of retaliation against an employee who complains, assists, or otherwise participates in the investigation of a complaint. This policy includes all forms of sexual harassment.

www.mesoscale.com

POSITION: Quality Assurance Manager

Reporting to the COO, The Quality Manager is responsible for leading the Quality processes for the company; assuring that Alcore products and services comply with customer contract requirements, engineering requirements, and company procedures; and managing the Quality Department staff.

Specific Job Responsibilities include:

• Developing and executing quality objectives complementary to corporate policies and goals.
• Developing and implementing standards and methods for inspection, evaluation, and testing to assure quality goals are met.
• Leading quality centered process improvement initiatives for the company.
• Overseeing the management, development, and, and motivation of the quality team staff.
• Developing and fostering policies and actions that motivate the quality focus and commitment of the workforce.
• Developing and maintaining relationships and partnerships with customers, stakeholders, and suppliers.
• Acting as designated quality management systems representative for AS9100 and NADCAP TG3-3-11.
• Overseeing the scheduling and performance of internal audits and certifications.
• Assisting in qualification processes.
• Appling statistical process control (SPC) methods to analyze data, evaluate current processes, and presenting related information to the Management Team.
• Supporting all Departments to answer quality related questions and provide problem solving support.

Quality Related Experience

Experience in a supervisory role demonstrating the ability to manage processes, procedures and individuals toward meeting quality goals.

Experience with corrective action and corrective action board processes, supplier quality standards, notices of escapements, and nonconformance management.

Education and/or Experience

Minimum Bachelor’s degree from an accredited college or university and related educational background in statistics, Quality Assurance practices, Engineering, or Lean Manufacturing. Background must demonstrate the ability to work with mathematical concepts such and apply these concepts to practical situations.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Alcore, Inc. is a leader in providing high-quality, lightweight structural core materials to the aerospace, marine, construction, rail and industrial markets. With a wide variety of structural honeycomb core materials, Alcore draws upon its broad engineering expertise, sophisticated 5-axis CNC machining, and added value processing to deliver solutions that are totally responsive to customer needs.

Alcore is part of the M. C. Gill Corporation Group of Companies. Alcore is located approx. 20 miles North of Baltimore, in Edgewood, Maryland, with separate facilities for metallic and non-metallic honeycomb operations.

Alcore’s FORM B facilities maintain ISO 9001:2000, AS 9100 Rev.B and NADCAP quality approvals.

Alcore offers careers in manufacturing, research and development, sales/marketing and administration. Our historical stability, integrity, the informal climate of our privately owned company, competitive employment benefits and long term growth make us an employer of choice for people who seek careers in composites manufacturing primarily related to aerospace.

Additional information on Alcore is available at our websites, Alcore.com and at MCGILL.com.

Cover Letters and Resumes sent in application for this position should be addressed to .