Quality Compliance Engineer

What You Will Do as Quality Compliance Engineer

• Plan, deliver and support internal audits of the Quality Management System and Good Manufacturing Practices (GMP) in line with audit schedules
• Issue clear audit reports and raise follow-up actions, ensuring timely tracking and verification of effectiveness audits
• Carry out regulatory compliance checks, supporting readiness for internal, customer and third‑party audit activities
• Complete compliance checks against ISO 13485, MDSAP and EU MDR
• Support Third Party regulatory audits and customer audits with a confident, process‑driven approach

What You Will Bring as Quality Compliance Engineer

• Auditing experience aligned with ISO 13485, MDSAP and EU MDR requirements
• Strong knowledge of MDSAP and EU MDR regulatory expectations
• Experience with NPI/ECN, CAPA and concessions processes is desirable
• Excellent attention to detail, with resilience and tenacity to see actions through to completion
• Strong verbal and written communication, with the ability to work with minimal supervision

This Quality Compliance Engineer role directly supports this company's mission around quality, reliability and regulatory confidence across product and operational activities. By ensuring robust audit readiness and effective compliance monitoring, you will help protect the quality system, strengthen decision‑making, and enable continuous improvement in areas that matter most.

Location

This Quality Compliance Engineer position is based in the Swansea area