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QA Manager (Medical Device/Combination Products)

Careerbuilder-US
Cambridge, MA, United States
Full-time
  • Experience in Pharma / Biotech / Medical Device background and Quality Assurance (minimum of 5-10 years)
  • Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
  • DOE / SPC process optimization & validation (IQ, OQ, PQ), P / DFMEA
  • BS or BE in Engineering and previous experience in the medical device and / or pharmaceutical industries
  • Product design / development (design control) from concept to post product launch for Europe (EMEA / CE Mark) & US (FDA / PMA / 510k) submissions
  • 9 hours ago
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