Alcore, Inc., Edgewood MD is seeking a QUALITY ASSURANCE ENGINEER to be part of our Quality Team.

Reporting to the Quality Manager, the QA Engineer will be responsible for departmental and company quality process and initiatives. Key to these responsibilities will be assuring compliance with customer quality requirements and maintaining AS9100 and ISO quality system standards

Related responsibilities will include:

• Overall supervision and development of the quality lab.

• Managing processes for quality system documentation, operational metrics, internal audits, corrective and preventive actions, and related SOPs, and company-wide quality training requirements.

• Developing and directing and participating in activities that support continuous improvement.

• Establishing and reinforcing positive working relationships within the department and between departments, customers, and suppliers.

• Formulating quality control programs involving the development and design of inspection instruments and devices, applications, methods and techniques.

Education, Key Skills, Experience:

• Degreed professional (Engineering or Quality) or a Minimum of five years in the Quality discipline.

• Demonstrated Problem Solving skills in including use of root cause analysis

• Demonstrated Ability to lead, create, promote, and sustain a vision of total quality and to motivate, persuade & inspire quality in the manufacturing team members.

• Ability to manage multiple complex projects and issues; to anticipate, negotiate & manage conflicts, involving work deadlines.

• Familiarity with Lean or six sigma methodology

• Direct manufacturing background with prior Aerospace products experience preferred.

• Active member of ASQ preferred.

• Proficiency in MS Office & other software as required, & ability to perform math calculations, measurement, analysis & reporting as required.

Alcore Corporation 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’s facilities maintain ISO 9001:2000, AS 9100 Rev.C 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.

Alcore is part of the M. C. Gill Corporation Group of Companies. Alcore is located approx. 20 miles North of Baltimore, Maryland with separate facilities for metallic and non-metallic honeycomb operations. http://www.mcgillcorp.com/alcore/careers.html

Interested individuals can forward their resume to

We have an opportunity for a Senior Quality Engineer in our Ohio and Florida facilities.

BASIC FUNCTIONS OF THE SENIOR QUALITY ENGINEER:

This position will oversee a diverse group of functional investigations that will be performed within the scope of the Quality department.

ESSENTIAL FUNCTIONS:

Conduct investigations into Medical Device Reports (MDR���s) with products with respect to applicable Federal regulations including 21 CFR 820, 803 and in accordance with ISO 13485 and internal Standard Operating Procedures

Assume lead role in investigating potential manufacturing / process issues with a goal of identifying potential root cause and assessing potential finished device impact

Investigation, monitoring, and follow up on CAPAs for completion and effectiveness

Author and approve investigation findings

Communicate with company personnel as to status of complaint investigation, recommended course of action, and the need for additional medical and/or supplementary information relevant to complaint investigations

Communicate with Quality departments as to the status of product analysis and the need for additional information relevant to the report

Able to participate in Risk Analysis activities including FMEA and PFMEA

Attention to detail and skill at auditing to ensure accuracy

Ability to work cross-functionally with various groups that have opportunity to impact the investigation outcome (Engineering, Operations, Quality, Commercial Operations, etc.)

Work closely with Quality Audit to assess current procedures/work instructions related to Quality and address deviations/findings

Monitor complaints received and provide trending and metrics as determined necessary for inclusion in management review

Review as needed Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release

Complete special projects as required in support of the location���s Quality function

REQUIREMENTS FOR THE POSITION:

Bachelors in Engineering or science related field

Experience working with heavy equipment and machinery

Five (5) years of process engineering, quality engineering, or investigatory experience in the medical device or FDA regulated field

Prior experience with root cause investigation tools and complaint file documentation

Knowledge of FDA (21CFR 803/806/820) and ISO (ISO:13485) regulations

Organized and details oriented; proven ability to meet deadlines

Strong analytical skills; verbal, and written communication skills

Ability to work individually and as part of teams

PC knowledge to include MS Word, Excel, PowerPoint, Access & Visio, and database management

Janet G. Shields
Human Resources-Talent Acquisition

440.329.6942

INVACARE CORPORATION
One Invacare Way
Elyria, OH 44035
invacare.com

idX is a leading custom store fixture manufacturer with facilities strategically located throughout North America and operations expanding globally into Asia. Visit www.idxcorporation.com for more information about our growing company.

idX Baltimore is seeking a Quality Assurance Technician to assist with the quality inspections of our product. This person must have excellent organizational skills, ability to learn quickly, multi-tasking capabilities, ability to read and interpret engineering drawings and standards, good verbal and written communication, ability to create and maintain spreadsheets along with a basic understanding of manufacturing computer software (ERP preferred) and be very attentive to details. This person must have 3-5 years experience in a wood/metal/acrylic manufacturing environment.

Responsibilities would include but are not limited to:

• Inspect and audit quality of product

• Assist with communication and problem solving efforts

• Document and maintain customer quality expectations and assure communication to production teams

• Understand machining standards

• Work together with teams to assure continuous improvement

• Maintain COQ reporting

Qualified applicants please submit resume with salary history to

Quality Assurance Specialist (MD – Annapolis Junction )
http://www.rayjobs.com/index.cfm?aReq=27498BR

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: INSPECTOR – Process Assessor

Business Sector: : Electronic Systems

Location: : United States-Maryland-Baltimore

US Citizenship Required for this Position: : Yes

Northrop Grumman Electronic Systems currently has exciting opportunities available for Inspector – Process Assessors

In this position, you will perform all process, product inspections of purchased/manufactured components and assemblies for development and production programs. You will also determine overall product compliance by performing process and product evaluations via process monitor and/or auditing for capability and control. This is an IUE Union Represented position.

Candidates must be either certified as an ASQ-Certified Mechanical Inspector or comparable certification program or have successfully completed accredited (3 credit) college courses* in each of the following areas: Quality Concepts in Manufacturing (typical course content includes quality practices, continuous improvement, statistical process control, auditing, etc.); Shop Math – including Trigonometry, Geometry and Introductory Algebra; Geometric Dimensioning and Tolerancing per ANSI Y14.5; and Part Measurement and Gauging Techniques. Must have 3-5 years prior industrial experience in a Technology environment involving microelectronic, aerospace electronic fabrication and assembly. High School diploma or GED. Knowledge of the manufacturing process (electronic & mechanical products). Competency in Microsoft word. No clearance is required.

*Submit official transcripts and course descriptions at the time of application.

Preferred Qualifications: Competency with basic computer skills including Microsoft excel and a working knowledge of SAP. Good people skills are a plus in addition to being able to work in a team environment including being able to perform in a multi-disciplined IPT (Team) environment determining priorities, and offering solutions to diversified requirements.

Northrop Grumman Corporation is a leading global security company whose 75,000 employees provide innovative systems, products, and solutions in aerospace, electronics, information systems and technical services to government and commercial customers worldwide.

Northrop Grumman is an Equal Opportunity Employer committed to hiring and retaining a diverse workforce regardless of age. U.S. Citizenship is required for most positions.

For additional information, go to CAREERS and go to ID#12006880 or contact . Location: United States-Maryland-Baltimore (area)

Calibration Technician needed for AS9100 Aerospace enterprise in the Baltimore area.

Associates Degree required, however will consider based on experience.

Duties include but no limited too gage calibration system, inventory of all plant gaging, managing the GAGEPACK database, oven calibrations and TUS surveys.

In addition, any other duties required by management.

Strong initiative, pro-active mindset and desire to grow beyond the position required.

PathSensors, Inc. is a growing life science manufacturing company. We are currently seeking qualified candidates for the position of Manager / Director of Manufacturing and Quality systems. The successful candidate will be responsible for building quality systems, leading manufacturing operations, hiring and training production workforce and interfacing with customers.

Company:

PathSensors is a manufacturer of rapid pathogen detection systems. The company employs a novel biosensor based technology (CANARY) licensed from MIT Lincoln Laboratories.

For more information visit: http://www.pathsensors.com

PathSensors, Inc. offers a competitive compensation and benefits package, along with future growth opportunities.

Position Description:

This position is responsible for the production of instrumentation (via third party manufactures), reagents and disposables. The manager / director will also, lead the development of Quality Systems related to the manufacture, processing, packaging and distribution of instrumentation and consumables.

- Work closely with the executive team to develop company strategy and milestones

- Direct suppliers on product performance, cost and delivery

- Manage production operations

- Lead the development and deployment of quality systems

Position Responsibilities:

- Lead the manufacture of commercial biologics

- Staff and scale-up the manufacturing organization

- Develop, coach and train personnel

- Build ISO 13485 caliber quality systems for all manufacturing processes

- Plan and direct manufacturing operations and production schedules

- Manage the delivery of instrumentation from third party OEM¡¦s

- Build Kanban systems for inventory management

- Support the launch of new products

- Track key result indicators

- Build cross functional relationships throughout the organization

Key Result Indicators:

- On time delivery

- DPMO quality performance tracking

- Develop production and shipment schedules in coordination with sales

- Maintain up-to-date routing sheets and BOM¡¦s for all products

- Successful launch of new products

- Manage department budget and staffing

- Ensure a safe work environment by driving safe behaviors

Background:

- Education — MS / BS / PhD in life sciences or biomedical / biochemical engineering

- 10 years of work experience in pilot or commercial biologics manufacturing

- 7+ years of supervisory / management experience

- Industrial experience with mammalian cell culture

- Intimate knowledge of ISO quality systems

- in vitro diagnostics

Demonstrated skills:

- Supervisory experience in a production organization

- Strong work ethic

- Project Management

- Strong verbal and written skills

- Presentations skills to small and large groups

- Ability to work in a team environment

- Demonstrated background in six sigma (green belt or better)

Applicants, please submit your resume and cover letter to HR@pathsensors.com.

_________________________________________________

PathSensors does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on PathSensors approved agency list. Unsolicited resumes or candidate information submitted to PathSensors by search/recruiting agencies not already on PathSensors approved agency list shall become the property of PathSensors and if the candidate is subsequently hired by PathSensors, PathSensors shall not awe any fee to the submitting agency.

PathSensors is an Equal Opportunity/ Affirmitive Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status or any other characteristic protected by federal, state or local law.

Information submitted will be used by PathSensors for activities related to your prospective employment.

Supplier Quality Engineer
Tracking Code
1802
Job Description

This position offers the right candidate an exciting opportunity to support the Quality and processes of our growing Product Suite as part of the Logistics Team. This position combines the administrative and daily QA tasks, including inspection of products, reporting, and process assessment. This fast growing, dynamic environment could provide the right candidate with the opportunity to grow his/her career in a number of directions.

Responsibilities:
-       Support ISO 9000 Activities
-       Obtain root cause analysis for returned equipment and quality issues
-       Assure timely corrective action implementation
-       Assist in coordination of First Articles
-       Perform Incoming Inspection activities
-       Coordinate MRB and CAR log in a timely manner
-       Resolve Quality issues with Integrators and Suppliers expeditiously
-       Maintain quality and product associated metrics

Required Skills

Specific experience:
-       Root cause analysis, Corrective and Preventive Actions
-       Incoming Inspection and MRB Meetings
-       Quality Management Systems
-       ISO 9000 Internal auditing experience is a plus
-       Continuous Improvement experience preferred (Six Sigma, Lean, etc.)
-       2 – 5 Years experience in Supplier Quality, RMA or Quality Control function
-       Software /Hardware/ Electronics Industry experience is a strong plus

Education/Qualifications:
-       Candidates with ASQ Lean Certification SME / AME, Quality Auditor CQA or Quality Engineer CQE preferred.
-       Demonstrated experience in hands-on inspection techniques, reporting and root cause analysis.
-       Associate’s Degree from two-year college or technical school, or equivalent combination of education and experience. Candidates with BS Degree preferred.

Requirements:
-       Ability to direct the activities of others through data analysis and problem resolution projects.
-       Process oriented, keen attention to detail. Must be able to develop, monitor, and track the progress of an action plan.
-       Use quality-engineering experience to take a discerning look at existing processes and recognize risks and opportunities associated with current performance.
-       High level of initiative, self-direction, and accountability for actions required.
-       Excellent written and verbal communication skills.
Must be able to articulate quality issues in written reports and during internal and supplier or integrator meetings.
-       Excellent computer skills – Office suite for MAC, Oracle, Salesforce.Com.
-       Team player as well as an Individual contributor.
-       Ability to work in a Global Team, where members and suppliers are not co-located or in the same time zone.

Job Location
Columbia, MD, US.
Position Type
Full-Time/Regular

Posted at:  https://sourcefire.silkroad.com/epostings/index.cfm?fuseaction=app.jobinfo&jobid=304307&company_id=15640&version=1&source=ONLINE&jobOwner=961575&aid=1

Supplier Quality Engineer

Business Sector: : Electronic Systems

Location: : United States-Maryland-Baltimore

US Citizenship Required for this Position: : Yes

Relocation Assistance: No relocation assistance available

Description: Process Assessor (Inspector) – Perform all process, product inspections of purchased/manufactured components and assemblies for development and production programs. Determine overall product compliance by performing process and product evaluations via process monitor and/or auditing for capability and control.

Qualifications: Candidate must be either certified as an ASQ-Certified Mechanical Inspector or comparable certification program or have successfully completed accredited college courses in each of the following areas: technical mathematics, metrology, drawing interpretation, and basic statistics. High School diploma or GED. Knowledge of the manufacturing process (electronic & mechanical products). Competency in Microsoft word. No clearance is required. 3-5 years prior industrial experience in a Technology environment involving microelectronic, aerospace electronic fabrication and assembly.

Preferred Qualifications: Competency with basic computer skills including Microsoft excel and a working knowledge of SAP. Good people skills are a plus in addition to being able to work in a team environment including being able to perform in a multi-disciplined IPT (Team) environment determining priorities, and offering solutions to diversified requirements. CMM Programming experience in PC-DMIS a plus.

Northrop Grumman Corporation is a leading global security company whose 75,000 employees provide innovative systems, products, and solutions in aerospace, electronics, information systems and technical services to government and commercial customers worldwide.

Northrop Grumman is an Equal Opportunity Employer committed to hiring and retaining a diverse workforce regardless of age. U.S. Citizenship is required for most positions.

For additional information, go to CAREERS and go to ID#12001135 or contact .

Dept 820 PE1 Quality Assurance Engineer Job Description

Summary: Systems & Product Quality Engineer with service oriented architecture and zero defect design experience of electronics modules and microwave transceivers used in high volume serial automotive production environments, commercial satellite direct broadcast communication systems, bent-pipe and spot beam burst TDMA (VSAT) systems, portable and mobile satellite modems, fixed and mobile wireless digital communication network (cellular) and broadband carrier network (LMDS) equipment for medium to high volume consumer market.

Primary Function(s):

• The Systems & Product Assurance Quality Assurance Engineer will participate as a concurrent engineering team member working with the Product Line Manager, Design Engineers, Manufacturing Engineers and Test Engineers as part of the systems & product develop process. They will develop the Comprehensive Test Plan, design and execute the Quality Acceptance Tests in a laboratory environment. Practical knowledge of DFMEA, APQP, PFMEA, MSA, SPC, PPAP HW and SW reliability, maintainability and serviceability using industry tools such as Sherlock, RELEX is required. The QA Engineer will also provide in-house training to the Concurrent Engineering Team and implement the Hughes Quality Management System as it relates to the Concurrent Engineering development processes.

• Assess emerging technology’s capability to be reliably integrated into high volume designs of automotive, satellite terrestrial terminals & network operation equipment. This work includes the development of zero defect strategies/techniques and training for the design of circuits, test modes or processes to quantify design margin, product and systems quality gates. Design For Six Sigma (DFSS) experience is a must.

• Utilizing the outputs of the DFMEA & PFMEA, design and implement an in-line manufacturing Zero Defect Gate & sampled Product Assurance Test (PAT). The zero defect gate and PAT shall verify system level features/requirements and results summarized with a Quality Metric that includes software performance/stability. Hands-on experience in voice and data network engineering using industry test tools such as Spirent or IXIA, Windows/Linux Systems and CAN administration with troubleshooting and repair are essential. These include cellular, satellite, Wi-Fi, Bluetooth, WLAN and LANs.

• Working with the System Release and Launch Alpha/Beta teams, develop service oriented quality metrics (ie customer call rate, truck roll rate, advanced warranty replacements) to serve as quality gates to service launch. Includes post launch analyses of service quality metrics for fast feedback and corrective/preventive actions.

• Proficient in use of computer to develop database queries using Crystal Report, BiQuery, MiniTab and Excel to data mine and correlate service interruption events to customer call rate, truck roll rate, etc and drill down to root reasons and calculate normalized failure rates.

• Working in a Concurrent Engineering team, develop “zero defect models” to predict probability of shipping zero defects (ppm) based upon defects injected by design, parts, process, test and develop comprehensive end-to-end test coverage strategies commensurate to meet the zero defect goal. Ability to work in a cross-functional team to extract the model inputs from Manufacturing, Contract Manufacturer, Engineering, Test and Supplier Quality is essential.

• Working with manufacturing and contract manufacturer, allocate allowable part and solder process defect levels in printed circuit board assembly processing depending on defect opportunities or complexity of the assembly. Verify and correct if in-process defect control and outgoing quality after sample burn-in and product audit testing will not achieve end customer desired ppm goal.

• Develop and execute a System Level Product and Process Audit Plan to verify compliance to ISO 9000, TS16949 and VDA 6.0 as applicable; report findings assign action items and follow-up with corrective/preventive 8D reports.

Job Qualifications:

• Strong written and verbal communication skills

• Strong teamwork skills – ability to work well with others and influence the direction of projects

• Ability to perform as a project leader and direct the activities of others through data analysis and problem resolution projects

• Knowledge of hardware, software, and network architectures in support of consumers and enterprise customers

• Proficient in Software Quality Assurance practices, thorough knowledge in Hardware Development Processes, strong Network Engineering background and “hand-on” experience using broadband modems & data networking equipment for Launch & Service Qualification.

• Knowledge of Engineering, design and validation practices associated with “Customer facing Human User Interfaces.”

• Knowledge of Linux OS design architectures associated with managing a network of hybrid networks.

• Use Engineering experience to take a discerning look at existing processes and recognize risks and opportunities associated with current performance

• Ability to perform database queries using Crystal reports, BiQuery, MiniTab and Excel, format data, and perform statistical analysis of data

• Proficiency with Excel as a data analysis and graphical presentation tool

http://www.hughes.com/Careers/Pages/default.aspx

Mgr Reliability Analysis Lab 3

Requisition ID 12001959

Northrop Grumman : Electronic Systems

United States-Maryland-Baltimore

US Citizenship Required for this Position: : Yes

Clearance Type: Qualified for Secret

This position has responsibility for managing the engineering team supporting Failure and Reliability Analysis. The team of engineers advises Supply Chain Management, Mission Assurance, Manufacturing, and the Design organizations to root cause analysis of failures, reliability tests to derive statistically derived lifetimes based on models verified through life tests, and provide various support through the utilization of tools and techniques, such as, but not limited to, Scanning Electron Microscopy, Acoustic Microscopy, Focused Ion Milling and X-ray analysis.

Normal duties include performance objectives setting, tracking, and appraisal. Capital and expense budgeting as well as setting overall priorities.

The team is part of the Product Integrity organization and Hardware Design at the BWI campus.

Basic Qualifications:

The Reliability Analysis Lab manager candidate will be degreed in electrical, mechanical, or systems engineering and have more than five (5) years of experience in design, development or manufacturing with knowledge of failure analysis techniques, failure mechanisms, and reliability testing.. Knowledge and understanding of methods used for assembly of state-of-the-art devices is preferred. Background should also include experience with managing an engineering group. Familiarity of managing a lab is preferred as well as knowledge regarding environmental and performance testing. Requires Secret clearance and an ability to obtain and maintain Top Secret clearance.

Candidates who meet the basic qualifications of the position will be invited to complete a mandatory Northrop Grumman Electronic Systems Leadership Assessment developed by Gallup, a worldwide leader in strengths based selection. This assessment will help us learn more about you and the talents you might bring to a leadership position within the organization. The assessment is one component of the selection decision.

Northrop Grumman is an Equal Opportunity Employer committed to hiring and retaining a diverse workforce regardless of age. U.S. Citizenship is required for most positions.

For additional information, go to CAREERS-12001959 or contact .

Document Control Coordinator

Integra York

SUMMARY DESCRIPTION

This position administrates the change management process for controlled quality documentation in the York, PA facility. The associate is responsible for control and maintenance of all relevant quality system documentation, including standard operating procedures, work instructions, forms, labeling and external standards. Associate is also responsible for tracking quality system training.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Responsible for the establishment and maintenance of the document control system.

• Prior to circulating for approval, work with document initiators to assure proper formatting, spelling and clarity of text for any written documents submitted to document control.
• Track approval process and follow-up with initiator to assure all approval requests are completed in a timely fashion.
• Confirm that all edits are made appropriately in new and revised documentation after approval and prior to releasing for use.
• Maintains all standard operating procedures, work instructions, forms, product labeling files, etc. in accordance with all facility and corporate procedures as well as all regulatory requirements.
• Maintains revision and approval status of all documents
• Maintains hard copies of all approved documentation
• Maintains appropriate form templates for access from company intranet & SharePoint sites.
• Assures that all electronic documentation is protected from unauthorized use or modification.
• Updates computerized documents with data from change control documents and maintains archive of changed controlled documents and labeling.
• Act as contact point for Corporate for the issuance of new or revised corporate policies and procedures and provides notification to affected departments.
• Coordinates the annual review of all controlled documentation, per procedure.
• Assures accurate and appropriate archiving of all quality records as needed.

Coordinate with other departments to obtain and release new and revised promotional materials (PMAP) and product labeling (FLAP).

• Assign tracking numbers as required.
• Verify that current revisions of all Promotional Materials and Directions for Use are available electronically by updating CD and filing with hard copy of documentation.

Administrator for Quality System training program.

• Ensure that specified training has occurred as required, utilizing the training software on new/revised documents including procedures, work instructions, forms, prior to implementation etc.
• Updates training database, as directed by others, based on employee status.
• Provides reports of training to HR and other departments as required.

Participates in internal quality system audits to assure compliance to all facility and corporate SOPs and all regulatory requirements.

Other duties as assigned.

Background requirements:

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: High school diploma required. 2-4 year college education or certificate from certified business school preferred.

• Certifications:

• Certification as a Microsoft Office Specialist (or similar) preferred

• Certification as a Biomedical auditor preferred

• Experience:

• Minimum of 1-2 years experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage.

• Minimum of 1-2 years experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.

• Very strong word processing and document formatting skills using Microsoft Office suite (Word, Excel, SharePoint, etc.) required.

• Experience in technical writing for a regulated industry preferred.

• Experience managing documentation via Microsoft SharePoint preferred.

• Experience working in Oracle, Agile and TrackWise systems preferred.

• Must be able to observe company policies and safety procedures at all times.

• Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.

• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

If interested, please email your resume to: , or visit our website: http://www.integralife.com/careers

Complaint Investigator

Integra York

Investigates and tests products received as product complaints in order to identify manufacturing related causes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

• Performs complaint investigation and records applicable information, in accordance with established internal procedures and external government regulations.

• Quarantines nonconforming product, initiates nonconforming product reports, performs inventory transactions, and initiates CAPA/SCARs, as required.

• Communicates with the customer and/or sales rep, as needed to obtain details related to customer complaints.

• Interacts with customer service, sales reps, medical specialists, complaint investigators, and quality reviewers to share complaint related information.

• Assists in the generation customer complaint metrics and status updates to management, as required.

• Assist with maintenance of procedures, work instructions, and forms associated with the CAPA, and Complaint functions to create robust, efficient systems and facilitate overall compliance with government regulations and international Quality System Regulations (QSR).

• Additional duties, as required.

• Gives and welcomes constructive feedback; contributes to building a positive team spirit. Treats others with respect; works with integrity and ethically; upholds organizational values. Performs general housekeeping duties within the area.

• Observes company’s safety procedures and policy at all times.

Background requirements:

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: A high school diploma required.

• Certifications: ASQ or equivalent certification preferred

• Experience:

• Minimum of 3-5 years experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards.

• Minimum of 3-5 years experience in complaint handling.

• Experience in the use of mechanical measuring tools (vernier, calipers, micrometers, thread/plug gages, scales and hardness tester) is preferred.

• Able to interpret product specifications and engineering drawings.

• Demonstrated proficiency with computer office application software

• Must be able to observe company policies and safety procedures at all times.

• Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.

• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

If interested, please email your resume to: , or visit our website: http://www.integralife.com/careers

JOB ID: DC1202-001

TITLE: BLACK BELT/MASTER BLACK BELT for Public Sector Industry

LOCATION: DC/VA/MD (MUST BE LOCAL TO THE AREA)

The client currently does not pay for relocation, however, if you are still interested in this role please understand that all relocation costs will be your responsibility. Please encourage all interested parties to apply.

ABOUT THE LEADING NICHE

The Leading Niche® is a global management consulting firm that offers strategic, operational and financial management consulting. With major clients both domestically and internationally, the Firm’s worldwide consultants specialize across a number of industries and functions. The Leading Niche® prides itself on offering top-tier consulting services to clients while taking into consideration the nuisances of cultural and regional dynamics. Please visit us at www.theleadingniche.com.

ABOUT THE OPPORTUNITY

Our client is seeking someone that is available to commit to a minimum of 4 to 6 months with a potential to be extended up to 1 year and who can be onsite Monday through Friday. The pay rate for this role is currently $75/hr.

MINIMUM QUALIFICATIONS

• Must be eligible to work in the U.S., without sponsorship

• Certified Black Belt

• Certified at least 5 years

• Ability to successfully pass a background check and drug screen

• Ability to commit to the above time frame

PREFERRED QUALIFICATIONS

• Master Black Belt

• Lean Six Sigma Certified

• Public Sector experience

HOW TO APPLY

In the subject line of your email, please place JOB ID: DC1201-001. Forward your resume to .

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 @