Senior Quality Engineer

Barrington James; United Kingdom; On-site; GBP 60,000 - 90,000; Full time

Job summary

The ideal candidate has experience with Class II/III devices and a strong background in ISO 14971 and Design Assurance within a highly regulated environment.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

Cardiology / cardiovascular devices

Regulatory knowledge

V&V

CAPA

Design Controls

Job description

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.

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

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