Medical Device QS Engineer

Salt Lake City, UT

Job ID: 125455 Industry: Med

Medical Device Sr. Quality Systems Engineer

Environment:

Our client is a large medical device manufacturer.   They are in need of a quality systems engineer to help with a quality systems integration project.

Duties/Responsibilities:

This consultant will be responsible for helping with a Quality Systems Integration for our client of a newly acquired company.  They will be working with process owners to conduct gap assessments to our client’ s standards and be responsible for implementing compliant solutions for identified gaps. They will help implement new quality system technologies and corresponding processes to align with our client’ s processes.  This will be someone with a medical device background and they must have a firm understanding of both ISO 13485 & 21 CFR 820 regulations.  They must have great communication skills and be able to navigate within Microsoft office.  They must have extensive experience within quality systems.

Required:
  • Medical Device
  • ISO 13485 & 21 CFR 820
  • Quality Systems
  • Gap Assessment/Analysis
  • QS Integration/Harmonization

Job Type: Contract  

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