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Quality Control Manager, Device

  • Location Providence, Rhode Island
  • Job-type Permanent
  • Reference BBBH109425

COMPANY:

Global biotech company - Cell & Gene Therapy team

LOCATION:

Providence, RI

RELOCATION ASSISTANCE:

Yes

TITLE:

Quality Control Manager, Device - permanent, full-time

ROLE RESPONSIBILITIES:

  • 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

CANDIDATE REQUIREMENTS:

  • 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.