Medical Device Process Validation SME

TX

Job ID: 125740 Industry: Med

Medical Device Process Validation SME

Environment:

Our client is a large manufacturer of a variety of Diagnostic Catheter Medical Devices. They are currently in need of a hands-on Process Validation SME to drive and support a number of different Process Validation & Manufacturing Equipment Validation projects.

Principle Duties and Responsibilities:

The consultant will come from a Process and Manufacturing Engineering background within the Medical Device industry. The consultant will be responsible for writing Process Validation & Process Development documentation such as URS (User Requirement Specifications), writing & executing validation protocols (IQ/OQ/PQ), and Validation Summary Reports. This individual may additionally be responsible for performing Test Method Validations, and supporting Supplier Audits. This individual should also have experience in Injection Molding Processes & Equipment.

Required:
  • Medical Device
  • Process Validation
  • Process Development
  • Manufacturing Equipment Validation
  • Writing IQ, OQ, PQ
  • Injection Molding

Job Type: Contract  

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