Global biotech company - Cell & Gene Therapy team
Quality Control Manager, Device - permanent, full-time
- Manage and mentor at least 2 Analysts
- Serve as an SME for QC tests
- Execute QC tests the device program
- Execute materials characterization of polymers and adhesives, including the device membrane
- Evaluate properties of new and existing raw materials that are currently or will be used in development.
- Execute release and stability testing per RMS requirements for raw materials to be used in GMP manufacture
- BS or MS degree in a relevant, scientific area with a minimum of 5-7 years' experience and some medical device background (ISO 13485)
- Minimum 2 years of experience managing people (ideally in QC)
- Strong all-around knowledge of QA, validation and QC device regulations (e.g. 21CFR Parts 807 and 820, ISO 13485, ICH Q5C, ICH Q6B, ICH Q2, etc)
- Knowledge of polymer science and biomaterials
- Experience with implantation systems and Class I medical devices. Solid knowledge of device regulatory requirements (preferred)
If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details.