Quality Engineer I: CAPA & QMS Focus

Fresenius Medical Care; Sutton-in-Ashfield; On-site; GBP 32,000 - 46,000; 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 discounts

Job summary

Fresenius Medical Care in the United Kingdom is seeking a Quality Engineer I to support the Quality Management System, investigate non-conformities, and drive CAPA activities within our regulated manufacturing operations at our Huthwaite site. You will collaborate with R&D, Regulatory Affairs, and Manufacturing to ensure safe, compliant products.

The role requires 2-3 years in quality engineering in the medical device sector, ISO 13485 experience, and strong analytical/problem-solving skills.

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 environments, with knowledge of EU MDR and FDA regulations.

Responsibilities

• Support and continuously improve the Quality Management System (QMS).
• Investigate non-conformities and drive corrective and preventive actions (CAPA).
• Lead root cause investigations and verify corrective action effectiveness.
• Monitor quality data, trends, and KPIs to identify improvement opportunities.
• 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, and high-quality products.

Skills

CAPA

Non-conformance

Root cause analysis

Risk management

Statistical analysis

Regulatory awareness

Education

Bachelor’s degree in Engineering/Quality Management or related

Tools

MS Office

Electronic QMS systems

Job description

Fresenius Medical Care in the United Kingdom is seeking a Quality Engineer I to support the Quality Management System, investigate non-conformities, and drive CAPA activities within our regulated manufacturing operations at our Huthwaite site. You will collaborate with R&D, Regulatory Affairs, and Manufacturing to ensure safe, compliant products.

The role requires 2-3 years in quality engineering in the medical device sector, ISO 13485 experience, and strong analytical/problem-solving skills.