Medical Device Process Validation Specialist

Los Angeles, CA

Job ID: 124297 Industry: Med

 

Medical Device Process Validation Specialist 

Environment:

Our client is a large Medical Device manufacturer of a variety of Class I, II, and III products. This particular business unit is the client’ s Neurosurgical division. They are currently in need of a hands-on Process Validation Specialist to drive and support a long-term Process Validation Remediation project.

Principle Duties and Responsibilities:

The consultant will come from a Process Validation and Manufacturing background within the Medical Device industry.  This individual will be joining a team of  QE/Process Validation Specialists  who will be primarily be responsible for writing the client’ s Master Validation Plan. The consultant will also be writing process validation documents such as URS (User Requirement Specifications), and writing & executing IQ/OQ/PQ, and Validation Summary Reports. This individual may additionally be responsible for performing DOE' s, Gage R&R, PFMEA, and other Process Validation activities.

Required Experience:
  • Medical Device
  • Process Validation
  • Quality Engineering
  • Writing Process Validation Documentation
  • IQ/OQ/PQ

Plus:
  • Remediation Experience
  • Injection Molding

Job Type: Contract  

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