Quality Engineer - Medical Devices - Didcot

Newton Colmore Consulting; East Hagbourne; On-site; GBP 38,000 - 48,000; Full time

Benefits offered by this job

Private healthcare

Income protection

Life assurance

Pension scheme

Generous holiday

Job summary

Newton Colmore Consulting seeks a Quality Engineer to support development, manufacture and improvement of medical device technology in Didcot. The role focuses on CAPA, NC, complaints, change control, and audits to sustain ISO 13485 and regulatory compliance.

Candidate will help implement an eQMS, strengthen supplier quality through audits and quality agreements, and collaborate with engineering on validation and design-for-manufacture considerations. Travel minimal.

Qualifications

• 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, NC, 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.

Responsibilities

• Own key Quality Engineering activities including CAPA, non-conformities, complaints, change control and internal audits to ensure ongoing compliance with ISO 13485 and 21 CFR Part 820.
• Contribute to the implementation and management of an eQMS as the organisation scales.
• Focus on supplier quality management: evaluate and approve new suppliers, manage performance of existing partners, establish quality agreements 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 Engineering and Development teams on validation activities, design for manufacture considerations, calibration and maintenance programmes, and risk management.
• Investigate product and process issues, use appropriate tools to identify root cause, and drive continuous improvement across the business.

Skills

CAPA

Non-conformities

Complaints handling

Change control

Internal audits

eQMS

Education

Engineering or science background

Tools

eQMS

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.

Responsibilities

• Own key Quality Engineering activities including CAPA, non-conformities, complaints, change control and internal audits to ensure ongoing compliance with ISO 13485 and 21 CFR Part 820.
• Contribute to the implementation and management of an eQMS as the organisation scales.
• Focus on supplier quality management: evaluate and approve new suppliers, manage performance of existing partners, establish quality agreements 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. Travel is minimized by sharing duties across the Quality team.
• Collaborate with Engineering and Development teams on validation activities, design for manufacture considerations, calibration and maintenance programmes, and risk management.
• Investigate product and process issues, use appropriate tools to identify root cause, and drive continuous improvement across the business.

Qualifications

• 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, NC, 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.

Benefits

• Excellent starting salary, private healthcare, income protection, life assurance, a 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, apply promptly. Alternatively, submit your CV and a member of our team will be in touch to discuss next steps.