Barrington James
Senior Quality Engineer
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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.
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What you’ll be doing:
- 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
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The ideal background:
- Medical Device Quality Engineering experience
- Experience within 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
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