Quality Engineer – Medical Devices

Overview

Quality Engineer – Medical Devices – Didcot

A pioneering medical device company in Didcot is looking to appoint a Quality Engineer to support the continued development, manufacture and improvement of its life‑changing technology. Newton Colmore is recruiting for this position exclusively, meaning applications must be made directly through us to be considered.

This is a broad and impactful role within an established Quality function, offering involvement across the full Quality Management System. You will take ownership of key Quality Engineering activities including CAPA, non‑conformities, complaints, change control and internal audits, ensuring ongoing compliance with ISO 13485 and 21 CFR Part 820. You will also contribute to the implementation and management of an eQMS as the organisation continues to scale.

• T ake ownership of key Quality Engineering activities including CAPA, non-conformities, complaints, change control and internal audits, ensuring ongoing compliance with ISO 13485 and 21 CFR Part 820. You will also contribute to the implementation and management of an eQMS as the organisation continues to scale.
• Part of the position will focus on supplier quality management. You will evaluate and approve new suppliers, manage the performance of existing partners, ensure quality agreements are in place and lead supplier audits both remotely and onsite.
• Support manufacturing quality by reviewing batch records, establishing quality checkpoints, creating KPIs and helping to embed compliant, efficient production processes. This duty is split across the Quality team, so to reduce the amount of travel needed.
• Work closely with Engineering and Development teams on validation activities, design for manufacture considerations, calibration and maintenance programmes, and risk management.
• Play a central role in investigating product and process issues, using appropriate tools to identify root cause and drive continuous improvement across the business.

• Evaluate and approve new suppliers, manage performance of existing partners, ensure quality agreements are in place and lead supplier audits (remote and onsite).

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

• Salary to reflect experience.
• Private healthcare, income protection, life assurance, pension scheme and generous holiday allowance.

Interest in this role is expected to be high. If this opportunity aligns with your experience and ambitions, we encourage you to apply promptly.

To discuss the position in more detail, contact Andrew Welsh, Director of Medical Devices, Biotech and Deep Tech Recruitment at Newton Colmore, on . Alternatively, submit your CV and a member of our team will be in touch to discuss next steps.