Quality Assurance Mgr - Medical Device
Safari Solutions - Indianapolis, IN

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As our Quality Assurance Manager , you will oversee Quality System training, Document Control and Final QA inspection. Through diligent training and documentation , lead your Quality Assurance team to ensure our Quality System is followed throughout the manufacturing process. Reporting to the Director of QA/QC, join our dynamic team in adopting a " quality in everything we do" approach.

  • Manage Quality Assurance Team :
      • Evaluate (hires, performance reviews, disciplines)

      • Train quality control personnel.

      • Implement and maintains quality system documentation.

      • Assists in creation and archival of design history and validation files.

  • Directs and coordinates performance for final QA inspections of packaged test strips and analyzers.
  • Maintains quality system records .
  • Generates quality assurance reports , including technical files and risk analysis, according to established guidelines and criteria.
  • Hands on involvement with QA personnel, requiring creation of quality system documentation.
  • Audits device history records.

  • Bachelor's degree in Chemistry, Biology or any related field is required.
  • Minimum 5 years of documentation or related experience is required.
  • Working knowledge of applicable FDA and ISO regulations is preferred.
  • Excellent leadership and communication skills with adept abilities to interface with multiple disciplines within the company.


Polymer Technology Systems, Inc . will reward your talents with an attractive salary plus possible incentive opportunity . You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with generous company match.


If you are a QA leader , we encourage you to apply online now . We prefer that you submit an electronic resume via this career site.

To learn more about Polymer Technology Systems , please visit www.cardiochek.com .

Polymer Technology Systems requests that all candidate and recruiter inquiries be directed to Safari Solutions.

Drew Smith, HR Consultant

Safari Solutions