Senior Quality Engineer

Senior Quality Engineer – Cardiovascular Medical Devices

UK | Medical Devices | Cardiology | Cardiovascular | Connected Devices

Are you a Quality Engineer with experience in cardiovascular or cardiac medical devices
?

I’m currently working with an innovative UK medical device organisation developing next-generation cardiovascular technologies
, and they’re looking for a Senior Quality Engineer to join the team.

This is a great opportunity to work on products where quality, reliability and patient safety really matter
, supporting complex medical devices from early-stage development through to commercialisation.

• Supporting Quality across the full medical device product lifecycle
• Managing Design Controls, Risk Management and V&V activities
• Supporting the development and integration of complex medical devices
• Driving CAPA, deviations, change controls and continuous improvement
• Working closely with R&D, Regulatory, Manufacturing and Supplier teams
• Ensuring compliance with ISO 13485, ISO 14971, FDA 21 CFR 820 and relevant UK/EU regulations

• Medical Device Quality Engineering experience
• Experience with in Cardiology, Cardiovascular or other interventional devices
• Experience with Class II/III medical devices
• Strong ISO 14971 and Design Assurance knowledge
• Experience across NPI, product development and V&V
• Experience working within a highly regulated medical device environment