Senior Quality Engineer – Medical Devices Compliance

Embecta Corp.; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Embecta Corp. in the United States seeks a regulatory/quality engineer to support FDA QSR, ISO 13485 and ISO 14971 compliant investigations. You will perform FTIR analysis and program lab equipment like Chatillon, while maintaining GLP and enforcing hazmat/biohazard protocols.

Additionally, you will provide audit support and review complaint investigations for compliance, contributing to Embecta's insulin delivery and diabetes care solutions worldwide.

Qualifications

• Relevant regulatory experience in medical devices is required.
• Experience with FDA QSR, ISO 13485, ISO 14971, CAPA, and audit management is preferred.
• Strong understanding of regulatory documentation and audit processes.

Responsibilities

• Ensure complaint investigations comply with FDA QSR, ISO, and Medical Device Directives.
• Maintain GLP and enforce equipment, hazmat, and biohazard protocols.
• Perform FTIR analysis and program lab equipment like Chatillon.
• Provide audit support and review complaint investigations for compliance.

Education

Master’s in Engineering + 3 years

Bachelor’s + 5 years

Job description

Embecta Corp. in the United States seeks a regulatory/quality engineer to support FDA QSR, ISO 13485 and ISO 14971 compliant investigations. You will perform FTIR analysis and program lab equipment like Chatillon, while maintaining GLP and enforcing hazmat/biohazard protocols.

Additionally, you will provide audit support and review complaint investigations for compliance, contributing to Embecta's insulin delivery and diabetes care solutions worldwide.