Medical Device Software Validation

New York City, NY

Job ID: 129395 Industry: Med

 

Medical Device Software Validation

Environment

The client makes a variety of medical devices that recently spun off from a larger company.

Responsibilities:

The consultant will be from a Medical Device background, with hands-on experience performing Software Quality review and approval, Software Validation strategy/documentation, writing protocols (IQ/OQ/PQ), and User Requirements Specifications (URS).This person will be Reviewing/Updating validation deliverables, protocols, scripts,  Traceability Matrix, OQ/PQ reports, and Deviations. Must be well versed in GxP, and CFR Part 11. Also must have a thorough understanding of Software Development Life Cycle (SDLC), processes/procedures, and waterfall methodologies to perform end to end quality assurance testing. Our client is looking for someone that can take the lead, identify problems, and find a way to resolve any issues if any. Looking for someone with 5-7 years experience. 

Essential:
  • Software Validation
  • Software Development Life Cycle (SDLC)
  • IQ, OQ, PQ

Desired:
  • SAP system validation

Job Type: Contract  

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