Offer summary
Qualifications:
Bachelor's degree in Life Sciences or Engineering, 2-3 years experience in compliance or quality assurance, In-depth knowledge of ISO 13485 and FDA regulations, Familiarity with Good Manufacturing Practices (GMP), Lead auditor certification is a plus.
Key responsabilities:
- Coordinate and track CAPA system
- Perform root cause analysis related to CAPA
- Conduct internal and supplier audits
- Create monthly analysis of audits and CAPA status
- Support external audits and quality projects