Associate Engineer- Quality
Oakland-Fremont-Pleasanton Metro Area, CA
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.