Quality Engineer I — CAPA & Continuous Improvement

Fresenius Medical Care; Huthwaite; On-site; GBP 35,000 - 50,000; Full time

Benefits offered by this job

Company Pension Scheme

Life Assurance

33 Days Holiday (incl. 8 bank holidays

Company paid health cash plan

Training and Development

Long Service Vouchers

Employee Assistance Program (EAP)

Blue Light card

Job summary

Fresenius Medical Care, a global leader in kidney care, seeks a Quality Engineer I for on-site work at the Huthwaite facility in the UK. You will support quality initiatives, investigate issues, drive NCCAPA activities, and contribute to validation programs across R&D, Regulatory Affairs and Manufacturing.

The role requires 2–3 years in quality engineering within medical devices, ISO 13485 familiarity, CAPA and risk management expertise, and strong analytical skills in a regulated setting.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, Biomedical Engineering, Industrial Engineering, Chemical Engineering, or a related technical discipline.
• 2-3 years' experience in a Quality Engineering or similar role within the medical device industry.
• Experience in ISO 13485 environment; knowledge of EU MDR and FDA regulations.
• Understanding of CAPA, non-conformance, complaint handling, change control, and risk management.

Responsibilities

• Support and continuously improve the Quality Management System (QMS).
• Investigate non-conformities and drive CAPA actions.
• Lead root cause investigations and verify corrective action effectiveness.
• Monitor quality data, trends and KPIs to identify improvements.
• Support validation, risk management, and compliance activities.
• Lead complaint investigations and quality improvement projects.
• Promote a culture of quality and continuous improvement.
• Collaborate with cross-functional teams to ensure safe, compliant, high-quality products.

Skills

Quality mindset

Analytical thinking

Problem-solving

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s degree in Engineering or related technical discipline

Tools

Microsoft Office

Electronic QMS systems

Job description

Fresenius Medical Care, a global leader in kidney care, seeks a Quality Engineer I for on-site work at the Huthwaite facility in the UK. You will support quality initiatives, investigate issues, drive NCCAPA activities, and contribute to validation programs across R&D, Regulatory Affairs and Manufacturing.

The role requires 2–3 years in quality engineering within medical devices, ISO 13485 familiarity, CAPA and risk management expertise, and strong analytical skills in a regulated setting.