Plant Quality Assurance Management Representative

W. L. Gore & Associates has demonstrated a high-energy commitment to innovation over its 48-year history. Hundreds of products for demanding fabric, medical, electronic and industrial applications have grown out of our commitment to the creation of new, ever-better technologies. That spirit of innovation, challenge, and opportunity combines in a uniquely creative work environment and has contributed to Gore's repeated listing among the "100 Best Companies to Work for in America". Additional information is available about W. L. Gore on our website at www.gore.com



W.L. Gore & Associates, Inc. Medical Products Division is seeking an individual to take on a broad range of responsibilities as a Plant Quality Assurance Management Representative in one of the manufacturing facilities and as a member of the divisional Quality Assurance team. This opportunity entails overall responsibility working with the plant leadership team, including developing strategic QA resource plans, leading the quality assurance function within the facility, prioritizing QA activities in alignment with business priorities with plant and segment leadership, executing QA plans as outlined in the business plan and driving results, and routinely interacting with divisional quality assurance leadership. This position will also require the associate to function as the facility quality management representative, developing policies and procedures which affect operational and compliance status and working with the divisional quality management representatives as appropriate. In addition, this commitment includes acting as the primary associate responsible for handling logistics and support in preparation for and leadership during and after internal and external inspections. This individual will also provide strong leadership and mentorship to quality assurance associates (and others), help to insure plant and project teams are prepared to engage with functional groups including (but not limited to) the MRB and MPRB, lead facility efforts to address product issues, provide direction to the implementation of effective corrective actions and review the results of monitoring of post-implementation effectiveness. Additional responsibilities include a focus on design control and other activities in support of new product development, systems enhancement (including software implementation and validation), working with engineering to enhance process yields, compliance auditing, working with procurement and engineering to select and approve vendors, associate training, and demonstrating strong support for our culture. Further responsibilities may include: Advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.); initiation of change documentation; preparation of quality reports and presentations; review of complaints.

Qualifications
Bachelor's degree in an applicable science or engineering (or a two-year degree plus significant medical device experience or significant medical device experience in a Quality Assurance role). Must have at least ten years medical device or pharmaceutical industry experience in quality assurance (with a minimum of 5 years in a documented quality assurance leadership role) and a demonstrated track record of successful Quality Assurance leadership. The successful candidate will also have demonstrated experience in successful partnership with other leadership functions (Business, Engineering, Manufacturing, etc.), Us and International Regulatory functions and will have served for a minimum of 3 years as the primary contact for US FDA and Notified Body facility inspections (or other similar regulatory body inspections). Additional documented experience in the following areas is also required: Demonstrated excellent written and oral communication skills, strong interpersonal skills, conflict resolution, quality systems implementation and maintenance; statistics; Design control, GMP/Quality System Regulations; ISO 9000/EN46000/ISO13485, vendor and process auditing (including certified auditor training); product/process/software validation; generation of change control documents; document control; and receiving inspection. Basic computer literacy is required.

Desirable:
Advanced degree(s) in an applicable science, engineering and/or business. Experience in PMA and 510K preparation and submissions, business operations, project management, budgeting and resource planning, mentoring, working with catheter-based technologies, advanced computer literacy, familiarity with ERP/MRP, MRS, and quality software systems (e.g., complaint, document control, etc.).



W. L. Gore & Associates, Inc. is an equal opportunity employer.
For further information regarding Gore, visit our website at www.gore.com