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Sr. Quality Assurance Engineer

Portage, MI 49002 | Work from home flexibility

Posted: 05/16/2023 Job Type: Contract Industry: Engineering Job Number: 22777 Pay Rate: $ 65.00 - $ 70.00

Job Description

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Quality Assurance Engineer for a 12 Month Contract opportunity. Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Position Description


This Quality Engineer role is in support of recent a acquisition, where the QMS of an acquired company must be merged with the existing QMS. Experience in process flow mapping and documentation desire.


  • Gather and analyze data to identify opportunities for quality improvements. 
  • Drive failure investigation to root cause when applicable using known engineering problem solving techniques. 
  • Lead an/or support NC/CAPA process and NC/CAPA investigations stemming from Post market. 
  • Resolve potential Medical device reporting (MDR) investigations. 
  • Lead product failure investigations to completion. 
  • Champion product failure investigations to closure. 
  • Document each investigation thoroughly in accordance with the internal procedures within complaint handling systems(s). 
  • Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required. 
  • Provide service report and complaint trending. 



  • Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
  • Minimum of 3-5 years in a quality role for a medical device company:  this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
  • Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable 
  • Excellent verbal, written and interpersonal communication skills 
  • Excellent problem solving and analytical skills 
  • Excellent technical writing skills 
  • High level of attention to detail and organization 
  • Prior related experience in a regulated environment highly desired. 
  • Prior related experience investigating, troubleshooting and root causing highly preferred. 
  • Participate in internal and external audits, as required. 
  • Trackwise experience highly desired.
  • Ability to read and interpret engineering drawings and other technical specifications preferred 
  • Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics) 
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