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Sr. Design QA Engineer (QMS Integration)

Portage, MI 49002

Posted: 01/25/2023 Job Type: Contract Industry: Engineering Job Number: 21371 Pay Rate: $ 70.00 - $ 70.00

Job Description

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Design Quality Assurance Engineer (QMS Integration)  for a 12 Month Contract. 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.  

 

CANDIDATES MUST HAVE AT LEAST 3 YEARS OF DESIGN-RELATED EXPERIENCE IN A REGULATED ENVIRONMENT

 

Position Description (Principle Duties and Responsibilities)

 

The Sr. Design Quality Assurance Engineer role is in support of a recent company acquisition, where the QMS of an acquired company must be merged with our clients' existing QMS. 

 

    • Experience in process flow mapping and documentation desired. 
    • Gather and analyze data to identify opportunities for quality improvements. 
    • Drive failure investigation to root cause when applicable using known engineering problem-solving techniques. 
    • Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required. 
    • Lead and/or Support NC/CAPA process and NC/CAPA Investigations stemming from Post market.
    • Resolve Potential Medical device reporting(MDR) investigations.
    • Document each investigation thoroughly in accordance with internal procedures within complaint handling system(s).
    • Provide Service Report and Complaint trending.
    • Manage projects in a timely manner. Participate in internal and external audits, as required. 
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Job Requirements

Requirements

  • Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
  • Minimum of 5 years of engineering experience with a preference for at least 3 years of design-related experience in a regulated environment. 
  • Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable 
  • Agile development methodology experience is highly desired 
  • Understanding and experience with product validation are highly desired 
  • Understanding of Medical Device design controls is 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) 
  • The job requires attention to detail in making evaluative judgments based on the analysis of information.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.) 
  • Must possess excellent oral and written communication skills

 

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