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Sr Engineer (Quality)

Orange County Metro Area, CA

Posted: 04/22/2019 Job Type: Engineering Job Number: JN -042019-24724
Sr Engineer (Quality)
Life Sciences Industry
Irvine, CA

The quality engineer will work with an experienced engineering team and have have responsibilities in the following areas:
  • Test method development
  • Test method validation
  • Design / Process Specification development
  • Risk Management specifically Risk Management Worksheet (MDR Compliance)
  • Design Verification
  • Equipment validation for design verification testing
Skills:
  • Medical device background in Quality (highly preferred)
  • Significant statistical knowledge pertaining to inspection method assessment.
  • Knowledge of inspection equipment.
  • Simple and electro-mechanical.
  • CMM / vision systems preferred.
  • Exposure to Tensil testing (highly preferred)
  • Catheter design verification and/or manufacturing experience preferred. (Balloon catheter type would be ideal)
Education:
  • Bachelor's Degree in Engineering
  • Minimum 3 years experience. 5 years preferred.
  • Quality and Six Sigma certifications preferred.
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