- Determine the implications of validations upon, Product Quality, Patient Safety, and Data Integrity.
- Determine process inputs and factors for variation where process capability is required.
- Responsible for reviewing Installation, Operating and Performance Qualification (IQ, OQ, PQ)s.
- Responsible for conducting Test Method Validations as required
- Develop/Review pFMEA documentation to support processes as part of Validation process
- Conduct investigation, bounding, documentation, review, and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
- 2 years' experience in a medium to high volume manufacturing environment and 1 year in a similar capacity in a regulated industry
- Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- A thorough understanding of GMP/ISO and validation regulations.
