Quality Engineer - Medical Devices Oxfordshire

Overview

Quality Engineer
- Medical Devices
- Didcot

A pioneering medical device company in Didcot is seeking a Quality Engineer to support the continued development, manufacture and improvement of its life‑changing technology. This role involves working across the full Quality Management System and taking ownership of key Quality Engineering activities to ensure ongoing compliance with ISO 13485 and 21 CFR Part 820. The role also supports the implementation and management of an eQMS as the organisation scales.

• Own key Quality Engineering activities including CAPA, non‑conformities, complaints, change control and internal audits.
• Ensure ongoing compliance with ISO 13485 and 21 CFR Part 820.
• Contribute to the implementation and management of an eQMS as the organisation scales.
• Part of supplier quality management: evaluate and approve new suppliers, manage performance of existing partners, ensure quality agreements are in place and lead supplier audits (remote and onsite).
• Support manufacturing quality by reviewing batch records, establishing quality checkpoints, creating KPIs and helping to embed compliant, efficient production processes.
• Collaborate with the Quality team to reduce travel by distributing duties across the team.
• Work closely with Engineering and Development teams on validation activities, design for manufacture considerations, calibration and maintenance programmes, and risk management.
• Investigate product and process issues, using appropriate tools to identify root cause and drive continuous improvement across the business.

• 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 of 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.

• Salary package with private healthcare, income protection, life assurance, pension scheme and generous holiday allowance.