Quality Systems Manager

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Milwaukee, WI
$115,000 - $130,000
Job Type
Direct Hire
Bachelor of Science
Oct 02, 2018
Job ID
Highly regarded medical device manufacturing site in the southern Milwaukee suburbs seeks a Quality Systems Manager to manage a quality systems team, plant-wide.  This division, with a focus on plastic and silicone medical device production, is part of an industry leading, global chemical company.  The Quality Systems Manager will:
  •  Maintain, improver and implement quality assurance programs to ensuring continuous production of products consistent with FDA QSR and ISO 13485 requirements.
  • Manage product complaints process, documentation control (procedures, change management, product release, label control, documentation), software validation, internal and external audits, supplier quality, CAPA, and oversight of the product/process/equipment validation program, and adequacy of deviations and non-conformances related to process or products.
Requirements for Quality Systems Manager:
  • Bachelor's degree in a scientific or technical discipline
  • 8+ years progressive experience in medical device quality assurance
  • 3+ years experience managing quality or engineering teams
  • A depth of experience in ISO 13485, and FDA 21 CFR Part 820
  • Strong project management skills
  • ASQ CQM, CQE, Certified Quality Manager preferred
  • Six Sigma Green or Black Belt 
  • Lean Manufacturing 
  • A track record of accomplishment in mentoring, developing and managing quality teams