Sr Quality System Engineer

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Sr Quality System Engineer

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    Sr Quality System Engineer
    • City:

      Eden Prairie
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The DAVIS Companies is supporting a global leader in the medical device industry by securing a Sr Systems Quality Engineer to lead the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. This person will also be creating and deploying quality system processes in support of QMS integration project. Lead initiatives to support MDD to MDR transition.

Primary Duties and Responsibilities:

  • Initiate, facilitate and/or manage projects to expand, change, enhance and improve the quality system, as assigned through the QMS integration project
  • Lead initiatives in support of QMS integration with sister company
  • Implement QMS updates needed to comply with MDD to MDR requirements
  • Support implementation of QMS with global partners
  • Create, review and maintain quality system SOPs, work instructions and other documents as assigned through Agile
  • Act as liaison for global corporate QMS with counterparts from other company facilities.
  • Provide quality system training for the organization.
  • Support QMS training activities and monitor process to ensure continued effectiveness.  Work with managers to assign appropriate training requirements for all employees.

Qualifications (Knowledge, Skills & Abilities): 

  • Bachelor degree or Master degree in Engineering.
  • 7 years Quality Systems experience
  • Demonstrated expertise and hands-on experience with FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Regulation, and other national and international regulations (MDSAP, etc.)
  • Ability to respond to inquiries from customers, regulatory agencies, or members of the business community. 
  • Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information clearly and concisely.
  • Demonstrated project management skills in order to plan, conduct and implement system assessments.
  • Experience with QMS integration project and working cross-functionally to drive project completion
  • Lead Auditor certification
  • Experience with Trackwise, Agile, other Audit and CAPA software tools


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