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Role Summary:
- Ensure complaint investigations comply with FDA QSR, ISO, and Medical Device Directives.
- Maintain GLP and enforce equipment, hazmat, and biohazard protocols.
Responsibilities:
- Perform FTIR analysis and program lab equipment like Chatillon.
- Provide audit support and review complaint investigations for compliance.
Qualifications:
- Master’s in Engineering + 3 years, or Bachelor’s + 5 years.
- Experience with 21 CFR 820, ISO 13485, ISO 14971, CAPA, and audit management.
Embecta
Embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are expanding our portfolio of solutions to serve more patients, healthcare providers, and communities worldwide.