Quality Engineer - Product Development - Medical Devices

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Irvine, CA
$1 - $2
Job Type
Direct Hire
Bachelor of Science
Jan 09, 2018
Job ID
Global medical devices leader seeks a Quality Engineer to lead new product development quality initiatives on a novel Class III medical device.  This position will be based in Costa Mesa, CA.  The Quality Engineer will focus on design control, design verification, validation failure analysis, CE Marking.  All candidates should have experience working in a dynamic environment, working both independently and on cross functional teams.  

  • Bachelor's degree in engineering, preferably mechanical engineering or biomedical engineering
  • 7+ years experience with strong progressive experience in medical device development or manufacturing
  • Experience with design control, design verification, validation failure analysis, CE Marking, FMEA, specification development, statistical reliability, quality and process control
  • Quality engineering experience in medical device new product development preferred
  • Knowledge of equipment qualification and design verification in the medical device industry or other regulated industries is required
  • Strong statistical knowledge
  • Strong communications skills, oral, written and electronic
  • The ability to travel approximately 10% to supplier/vendor sites