Quality Engineer - Medical Devices

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Irvine, CA
$1 - $2
Job Type
Direct Hire
Bachelor of Science
Jul 26, 2018
Job ID
Quality Engineer - Medical Devices

Global medical devices leader seeks a Quality Engineer to lead CAPA - corrective action -  initiatives at the company's flagship manufacturing site in the beautiful Salt Lake Valley area of Utah.  This highly regarded company offers excellent career growth opportunities across its many divisions, domestic and international.  The Quality Engineer will:  
  • Working with product and process owners and cross functional teams to develop and investigate nonconformance via CAPA process.  
  • Manage CAPA phase timelines.
  • Lead and assist with root cause analysis.
  • Manage the documentation and maintenance of CAPA files.
  • Conduct Root Cause Analysis and CAPA process training. 

  • Bachelor's degree in engineering or a technical discipline; advanced degree preferred
  • 6+ years experience in medical devices or a combination of medical devices and pharmaceuticals
  • A depth of experience running corrective action - CAPA in the medical device industry
  • Proven expertise in usage of MS Office Suite
  • Strong organizational and documentation skills
  • The ability to work effectively in a highly regulated, matrixed environment with diverse groups.
  • Strong electronic skills and working knowledge of statistical techniques
  • Working knowledge and understanding of statistical techniques
  • Substantial understanding and use of Root Cause Analysis tools
  • An understanding of the CAPA system
  • Substantial understanding of Investigation of Nonconformance
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Knowledge of and adherence to Quality systems regulations
  • Strict attention to detail