- The Quality Manager is responsible for product quality management and the QA team.
- Works with manufacturing teams on launch and management of medical devices & programs.
- Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts & Control Plans.
- Participate in product design (R&D) meetings with medical customers in relationship with understanding key quality deliverables. Responsible for Master Validation Reports.
- Drive cultural change.
- Relocation provided. $115K-$130K.
- The Quality Manager will have a BS degree with a life sciences related major. Must have practical knowledge of GMP, ISO13485.
- Minimum of 10 yrs. experience in product quality position, with direct experience in quality system compliance.
- Experience in medical device/life science (GxP) industry.
- Proficient in Microsoft Word, Excel, and PowerPoint. Knowledge of Quality Management software.
- Must be legally authorized to work in the U.S. and have a stable work history. Sponsorship is not available.