Sr./Princ. Manufacturing Quality Engineer - Medical Devices

Avon, MA at Gallin Associates

NO RELOCATION BUDGET

 

Early stage medical device company working on leading edge technology is seeking a senior level manufacturing Quality Engineer.  This role will lead the quality activities related to the manufacturing operation; Supplier and Manufacturing quality investigations, process and equipment validation, manufacturing documentation, inspection and test method development for QA, pilot and "first article build" assessment., manufacturing transfers, CAPA activities.

 

REQUIREMENTS:

 

MUST HAVE MEDICAL DEVICE EXPERIENCE

  • B.S. degree, preferably in science or engineering discipline
  • 10+ years experience in medical devices, with 5 years in high volume medical device manufacturing.
  • Strong ISO 13485 background
  • Experience leading the nonconforming materials and CAPA processes
  • Experience with supplier management controls and audits
 
 

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