Quality Engineer – Medical Devices

About the role

We are seeking a Quality Engineer to support the development, manufacture and continuous improvement of life‑changing medical device technology at a pioneering company in Didcot. The role sits within an established Quality function and offers involvement across the full Quality Management System.

Key responsibilities

• Own CAPA, non‑conformities, complaints, change control and internal audit activities to maintain ISO 13485 and 21 CFR Part 820 compliance.
• Support implementation and scaling of an electronic QMS (eQMS).
• Manage supplier quality – evaluate new suppliers, monitor existing partners, maintain quality agreements and lead remote and on‑site supplier audits.
• Assist manufacturing quality by reviewing batch records, establishing quality checkpoints, creating KPIs and embedding compliant production processes.
• Collaborate with Engineering and Development on validation, design‑for‑manufacture, calibration, maintenance programmes and risk management.
• Investigate product and process issues, perform root‑cause analysis and drive continuous improvement.

Required profile

• Experience in a highly regulated sector such as medical devices, biotech, pharmaceutical, aerospace or defence.
• Strong understanding of quality assurance and manufacturing processes.
• Hands‑on experience with CAPA, non‑conformities, complaints, change control and quality control activities.
• Knowledge of ISO 13485, MDR/UKCA and 21 CFR Part 820 is highly advantageous.
• Relevant engineering or science background preferred.

Required skills

• ISO 13485
• 21 CFR Part 820
• MDR/UKCA regulations
• Electronic QMS (eQMS) implementation
• Supplier audit and management
• Root‑cause analysis

What we offer

• Competitive starting salary
• Private healthcare, income protection and life assurance
• Pension scheme
• Generous holiday allowance
• Opportunity to contribute to transformative medical technology