Supplier Quality Engineer

Boston, MA

Job ID: 120336 Industry: Quality

 

Supplier Quality Engineer

Environment:

Our client is a large Medical Device manufacturer. They develop and manufacture a number of Class III cardiology  Medical Devices. They are in need of a hands-on Supplier Quality Engineer to support an  on-going remediation initiative  as well as  general supplier quality maintenance of business activities.

Principle Duties and Responsibilities:

The consultant will come from a Quality Engineering background for medical devices.  It is critical that they have experience as a Supplier Quality Engineer, as they will be responsible for remediating supplier issues, with qualifying supplier components as well as other SQE activities.  Those activities include SCARs, working with suppliers to update documentation, and helping to qualify other areas for suppliers. The Supplier QE must have strong communication skills and should feel comfortable in a client-facing capacity as they will be a liaison to suppliers.

The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters.

Required:
  • Medical Device
  • Supplier Quality Engineering
  • Qualifying Supplier Components
  • SCARs

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