Medical Device Quality Engineer

Chicago, IL

Job ID: 125349 Industry: Med

 

Medical Device Quality Engineer

Environment:

Our client is a large manufacturer and distributor of Medical Device products. They are currently in need of a Quality Engineer with strong Project Management skills to help support a number of on-going projects

Principle Duties and Responsibilities:

The consultant will come from a Medical Device Quality Engineering background and should have experience in Project Management, Quality Management Systems (QMS), CAPA, and Quality Auditing. The Quality Engineer Consultant will partner with CAPA Owners, and will work cross-functionally  with stakeholders in QA/R&D/Manufacturing/Operations to help drive CAPA processes and ensure successful CAPA closure. This individual MUST have strong Project Management skills (PMP Certification highly preferred), and should be able to manage multiple projects at once. Any experience with the latest ISO 13485: 2016 edition, and experience with FDA Medical Device Single Audit Program (MDSAP) are also both preferred.

Required Experience:
  • Medical Device
  • Quality Engineering
  • Project Management
  • QMS
  • CAPA

Preferred Experience:
  • PMP Certified
  • ISO 13485: 2016
  • MDSAP

Job Type: Contract  

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