Job Summary
A biotechnology company is seeking a Remote Early Detection Quality Engineer II or Senior Quality Engineer in Redwood City.
Individual must be able to fulfill the following responsibilities:
- Provide design controls guidance/support for IVD projects
- Lead all product Risk Management activities
- Ensure design changes are captured and follow the design change control process
Applicants must meet the following qualifications:
- Available to travel to headquarters at least a few times per year
- Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline
- 5 years of recent experience in an in vitro diagnostic (IVD) or medical device company
- 5+ years of quality experience in an FDA/ISO regulated environment
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IVDD, CLIA and CA requirements
- Knowledge of applying statistical analysis for testing