Quality Engineer I

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

Are you passionate about quality, continuous improvement, and ensuring products meet the highest standards? We are looking for a Quality Engineer I to play a key role in maintaining product quality, process effectiveness, and regulatory compliance with our manufacturing operations. In this role, you will support quality improvement initiatives, investigate quality issues, drive Non-Conformance, Corrective and Preventive Action (NCCAPA) activities, and contribute to validation programmes. Working cross-functionally with teams including R&D, Risk Management, Manufacturing Operations, Engineering, Supply Chain, and Regulatory Affairs, you will help ensure the consistent production of safe, reliable, and compliant products that make a difference to patients' lives. This is an excellent opportunity for a quality-focused professional who enjoys problem-solving, collaboration, and driving operational excellence in a regulated manufacturing environment. This is a full-time, on-site role based at our Head Office in Huthwaite - Nottinghamshire. Some overseas travel may be required.

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.

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 working within an ISO 13485-certified environment, with knowledge of EU MDR and FDA regulations.
• Understanding of CAPA, non-conformance, complaint handling, change control, and risk management processes.
• Strong analytical, problem-solving, organisational, and project management skills.
• Familiarity with quality tools, statistical analysis, validation activities, and electronic QMS systems.
• Proficient in Microsoft Office and comfortable working with cross-functional teams.
• Professional proficiency in English, both written and spoken.
• Six Sigma Yellow or Green Belt qualification is advantageous.
• Willingness to travel as required.

About Fresenius Medical Care

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision-"Creating a future worth living. For patients. Worldwide. Every day."-we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way - growing with purpose and leading kidney care with integrity and innovation

At our Huthwaite plant in the UK, we specialise in the production of high-quality HD liquid concentrate in canisters and bulk containers, as well as the manufacturing of Citrosteril disinfectants, essential components in dialysis therapy. With a dedicated team of approximately 20 full-time employees, our facility plays an important role in supporting Fresenius Medical Care's global mission to improve the lives of patients with kidney disease. By combining advanced manufacturing practices with strict quality standards, we help ensure safe and effective dialysis treatments worldwide. Join our passionate team and be part of this global impact!

Career Opportunities

• There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company

Benefits

• Company Pension Scheme
• Life Assurance
• 33 Days Holiday (inclusive of 8 days bank holiday) increasing with service
• Company paid health cash plan
• Training and Development
• Long Service Vouchers
• Employee Assistance Program (EAP)
• Blue Light card - providing thousands of amazing discounts online and on the high street

Quality Engineer posts will be subject to a Basic DBS Disclosure Fresenius Medical Care is an equal opportunities employer