Quality Systems Lead - Medical Devices - Stoughton

Employment Type

: Full-Time

Industry

: Miscellaneous



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NO RELOCATION BUDGET

Small medical device company working on cutting edge technology is seeking a hands-on Quality Systems lead. This role is responsible for managing the Quality System including developing S.O.P.s and providing quality support for manufacturing from incoming inspections to device acceptance. Full range of Quality support including supporting scale-up and transfer to 3rd-party CMs. Growth path to Quality Manager as organization scales.

REQUIREMENTS:

MUST HAVE MEDICAL DEVICE EXPERIENCE

  • B.S. degree, preferably in science or engineering discipline
  • 10+ years experience in medical devices, preferably with complex systems, not just components
  • Strong ISO 13485 background
  • 3+ years experience managing and maintaining QMS
  • Experience leading the nonconforming materials and CAPA processes
  • Experience with supplier management controls and audits

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