Medical Device QS SME

Boston, MA

Industry: Med Job Number: 131038

Medical Device Quality Systems  SME

Environment:

Our client is a medical device manufacturer of implant devices. They are in need of a Quality Systems SME to help with a new acquisition.

Principle Duties and Responsibilities:

The consultant will extensive experience in ISO 13485 environments, specifically performing Quality System GAP Assessments. Ideally this person will have helped with new Acquisitions & Mergers in the past. The client recently bought a new company and are looking to harmonize the quality systems. This person will help with the initial gap assessment, looking at best practices and ultimately help with the harmonization of the two QMS’ s. Required to work onsite with the parent company in Greater Boston but will be working closely with the organization that was bought out down south.

Required:
  • Medical Device: 8-10 yrs
  • Quality Systems: 8-10 years
  • GAP Assessments
  • ISO 13485, 21 CFR Part 820

Job Type: Contract 

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