Design Quality Engineer

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This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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Cure Talent is delighted to partner with an exciting British Medical Device Manufacturer, which, due to continued growth and investment, offers an opportunity for a Design Quality Engineer to join their Innovation team.

This is a hybrid role (3 days on-site per week) based in Bracknell, supporting the full product lifecycle of innovative medical technologies.

As a Design Quality Engineer
, you will ensure compliance with ISO 13485, ISO 14971, FDA QSR, and other relevant standards during development and post-market phases. You will collaborate with engineering, manufacturing, regulatory, and supply chain teams to drive product and process quality from concept to commercialization.

We seek an experienced Quality Assurance professional with proven Medical Device experience, especially in design control activities, including management of DHF and DMR.

Key Responsibilities:

• Provide quality support for product design, change control, and technical documentation.
• Review and approve engineering drawings, schematics, specifications, and verification plans.
• Support compliance with ISO 13485, ISO 14971, FDA design control, and other standards.
• Lead or participate in product risk assessments and maintain related documentation.
• Contribute to QMS development and improvement, including Design History Files and Device Master Records.
• Analyze complaint and field data to identify trends and drive CAPA activities.

The ideal candidate will have:

• A degree in Engineering, Life Sciences, or a related field (or equivalent experience).
• Proven QA experience within Medical Devices.
• Experience with Design Control Activities, DMR, and DHF management.
• Knowledge of ISO 13485, ISO 14971, FDA QSR, and design control principles.
• Familiarity with reviewing engineering documentation and technical drawings.

If you possess the necessary skills and experience, please contact the Cure Talent team today!