Quality & Regulatory Lead (PT)

AP Professionals
April 11, 2019
Rochester, New York
Job Type
Salary Range
$31K - $35K
Street Address
500 Linden Oaks


AP Professionals has partnered with a custom designer of medical equipment in Rochester, NY seeking a Part-time Quality and Regulatory Lead. This position will start part-time at 20-24 hours/week, but has the potential to shift into a full-time role if desired. This is a temp to possible hire role.


  • Lead and manage internal efforts to achieve ISO:9001 certification within the next six months
  • Lead and manage internal efforts to achieve ISO:13485 certification
  • Manage transition to a Class 1 medical device facility
  • Lead random FDA audits as required


  • Previous quality experience in an FDA regulated manufacturing environment strongly preferred
  • Medical device manufacturing experience strongly preferred
  • ISO experience required, preferably ISO:9001 and ISO:13485

Additional Qualifications

This position is not eligible for Visa sponsorship; US Citizenship or permanent residency status required

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