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Associate Engineer- Quality

Oakland-Fremont-Pleasanton Metro Area, California

Post Date: 08/12/2017 Job ID: JN -082017-19780
A premier diagnostic company has a staff level position for a Quality Associate:

Job Responsibilities and Expectations:
  • Serve as Quality Partner for local Quality Assurance Reviews, Equipment Non-conformances and Trackwise entry assuring completion in a timely and compliant manner.
  • Review and approval of Clinical Validation Plans, Clinical Protocols and Clinical Reports
  • Review and approval of local IQ/OQ protocols
  • Review and approval of Design History Files including Design Protocols, Reports and Plans
  • Provide assistance during audits of the Quality System and Clinical Operations
  • The candidate must have quality experience in an IVD or Medical Device company.
  • Experience working in a regulated environment (GMP or GCP)
  • Candidate must be able to work in a team environment and have great collaboration skills.
2- 5 years of related experience.

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