Medical Device Supplier Quality Engineer (Remediation)

Newark, NJ

Industry: Med Job Number: 129575

 

Medical Device Supplier Quality Engineer (Remediation)

Environment:

Our client is a large Medical Device manufacturer of class 3 devices. They develop and manufacture a number of Class III cardiac Medical Devices. They are in need of a hands-on Supplier Quality Engineer to support an  on-going remediation initiative, specifically helping with Supplier remediation of their current suppliers, as well as some supplier auditing. 

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, auditing current suppliers, 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.  This role may require some on site visits to suppliers in the area to be able to effectively execute supplier audits and SQE related activity efficiently. 

The resource must be proficient in the related ISO 13485 standards.

Required:
  • Medical Device
  • Supplier Quality Engineering
  • Certified Supplier Quality Auditor
  • Supplier Remediation experience
  • Qualifying Supplier Components
  • SCARs

Plus:
  • Certified Supplier Quality Auditor

Job Type: Contract

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