Quality Engineer – Medical Devices – Didcot

Newton Colmore Consulting Ltd; United Kingdom; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Private healthcare

Pension scheme

Life assurance

Generous holiday allowance

Job summary

Newton Colmore Consulting Ltd in Didcot is recruiting a Quality Engineer for the medical devices sector. You will own key Quality Engineering activities, including CAPA, non-conformities, complaints, change control and internal audits, ensuring ongoing ISO 13485 compliance and 21 CFR Part 820.

A focus on supplier quality management will be integral, with audits both remotely and onsite. You will support manufacturing quality through batch record review, quality checkpoints and KPI development,

Qualifications

• Experience in a highly regulated medical devices or similar sector.
• Hands-on CAPA, NC, complaints, change control and quality control activities.
• Knowledge of ISO 13485, MDR/UKCA and 21 CFR Part 820 is advantageous.
• Relevant engineering or science degree preferred.

Responsibilities

• Own quality engineering activities including CAPA, NC, complaints, change control and internal audits.
• Lead supplier audits and manage supplier quality performance.
• Review batch records and set quality checkpoints across production.
• Collaborate with Engineering on validation, DFM, calibration and risk management.
• Investigate product/process issues and drive continuous improvement.

Skills

CAPA

Non-conformities

Complaints handling

Quality Assurance

Risk management

Regulatory awareness

Education

Engineering or science background

Tools

eQMS

Audit management

Batch record review

Job description

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.

Responsibilities

• 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.

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).

Qualifications

• Experience within 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.

Benefits

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

How to apply

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 DeepTech Recruitment at Newton Colmore, on [phone]. Alternatively, submit your CV and a member of our team will be in touch to discuss next steps.