Sr. Supplier Quality Engineer - Medical Devices

Twitter Facebook
Irvine, CA
$100 - $200
Job Type
Direct Hire
Bachelor of Science
Feb 27, 2018
Job ID
Sr. Supplier Quality Engineer - Medical Devices

Industry leading medical devices company is seeking a Sr. Supplier Quality Engineer to join a new product team for an innovative cardiovascular implant.  Travel is anticipated to be 25%, U.S. and Europe.  This is an outstanding opportunity for an engineer to join an exciting new product launch team, with tremendous growth potential.  

  • Bachelor's degree in engineering 
  • 4+ years supplier quality experience in the medical devices
  • ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor or Six Sigma Black Belt certified preferred
  • Strong supplier quality audit experience, including experience developing audit plans, execute, and write effective audit findings
  • Experience running effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
  • Strong geometric dimensioning and tolerancing (GD&T) knowledge for print specifications
  • Strong understanding of Root Cause Analysis principles, FMEA process and development, GR&R  and process capability
  • A depth of experience in medical device Process Validation (IQ, OQ, PQ)
  • Experience developing supplier inspection plans incorporating critical quality features and risk analysis
  • Strong understanding of medical device manufacturing processes like injection molding, extrusion, machining.
  • Thorough understanding of risk management principles
  • Strong communication and organizational skills to effectively manage and get results with external suppliers