Job: Quality Assurance Professional (W L Gore; Elkton, MD)
Quality Assurance Professional
Description
W. L. Gore and Associates, Inc. is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we’ve been changing lives and changing industries including medical devices, fabrics, and electronics for more than 50 years.
Gore is seeking an individual to take on a broad range of responsibilities as a member of the General Medical Products Quality Assurance team. This associate will work on cross-functional teams to address product issues, define and implement effective corrective actions and monitor post-implementation effectiveness. In addition, this associate will become involved with operational improvements, product development and design control activities, systems enhancement (including software implementation and validation), compliance auditing, vendor selection and approval, and associate training. Further responsibilities may include: initiation of change documentation; advisory roles supporting various teams (such as raw materials inspection associates, document control, maintenance and calibration, environmental monitoring and control, etc.); preparation of quality reports; review of complaints; and development of policies and procedures which affect operational and compliance status.
Qualifications
Required:
* Bachelor’s degree in an applicable science or engineering. (In lieu of a BS, a two-year degree plus significant medical device industry experience in a Quality Assurance role is required.)
* Minimum of 5 years medical device or pharmaceutical industry experience in an operations role with Quality Assurance responsibility. (Medical device industry experience is strongly preferred.)
Additional documented experience in the following areas is also required:
* Excellent business judgment and decision making skills
* Demonstrated ability to lead a team through practical application of quality system principles
* Demonstrated ability to influence cross functional teams
* Excellent written and oral communication skills
* Strong interpersonal skills
* Strong conflict resolution skills
* Practical application of Quality System Regulations, specifically FDA regulations and ISO standards
* Quality Systems maintenance and improvement
* Working independently as well as part of a diverse team,
* Developing and driving projects to completion
Desirable:
* Ability to effectively influence individuals and teams across the organization
* Experience working with vendor and process auditing, product/process/software validation, generation of change control documents, document control and receiving inspection
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
EEO/AA Employer (applies to all positions located in the U.S.)
Job Number: 101352
Job Type: Experienced Professional
Job Function: Quality
Primary Location: North America-United States-Maryland-Elkton
Travel: Yes, 10% of the time
Shift: Day Job
http://www.gore.com/en_xx/careers/
