Quality Engineer - Medical Devices

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Milwaukee, WI
$75,000 - $85,000
Job Type
Direct Hire
Bachelor of Science
Apr 06, 2018
Job ID
Quality Engineer - Medical Devices

We are searching for a Quality Engineer for a highly regarded medical devices company in Wisconsin.  This company is located in a growing suburban community of 35,000 in the Chicago-Milwaukee I-94 corridor within easy driving distance of Milwaukee to the north, Chicago to the south, and Madison to the west. It has been listed on Money Magazines "Top 100 Best Places to Live". 

Our client is part of a large global chemical company and provides medical device contract manufacturing and support services to the healthcare industry worldwide. It specializes in silicone molding, precision medical extrusion of thermoplastics and silicone, and medical device assembly services.

The Quality Engineer will:

  • Develop, implement, and manages the CAPA program 
  • Support new product development activities including the development of Master Validation Plans, PFMEA’s, Control Plans, etc.
  • Develop, implement, manage internal audit programs and supplier quality programs
  • Support investigation and resolution of NCRs and CAPAs
  • Support validation activities
  • Assist in other CAPA activities as directed, including complaint failure investigations and customer communications
  • Own applicable Quality Systems related NCR/CAPAs
  • 4+ years experience in quality engineering in medical devices
  • Bachelor's degree in engineering or other applicable technical discipline
  • ASQ - CQE certification preferred
  • Experience running CAPAs
  • Internal and supplier audit experience
  • Strong working experience with ISO 13485
  • Lean training / certification preferred