Medical Device Manufacturing Quality Engineer

Detroit, MI

Job ID: 124982 Industry: Med


Medical Device Manufacturing Quality Engineer

Background: Our client is a large Medical Device manufacturer of  a number of Class I, II and III medical devices. They are in need of a number Manufacturing Quality Engineer resources to help with Manufacturing Process Development, Qualification, and Improvements. The individual will be from a Medical Device GMP background, with strong hands-on Manufacturing Engineering experience. They will also be responsible for reviewing/revising/writing Production Documentation, performing Process Validations and Manufacturing Equipment Validations, Manufacturing Inspections, and creating PFMEA’ s. Injection Molding Processes & Equipment experience is a huge plus. The consultant must be comfortable in a fast paced environment and able to hit the ground running.

  •           Support Manufacturing Process Development, Qualification, Improvements.
  •           Writing & Performing Manufacturing Process & Equipment Validation
  •           Reviewing/Revising/Writing Production Documentation
  •           Validation of Injection Molding Equipment
  •           Gage R&R/DOE
  •           IQ/OQ/PQ
  •           Executing on Work Instructions/SOP’ s
  •           Supporting R&D/Manufacturing Engineering Teams

  • Medical Device: 5-8 years
  • Manufacturing Quality Engineering
  • Manufacturing Process & Equipment Validation

Huge Plus:
  • Injection Molding

Job Type: Contract  

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