Quality Engineer (m/f/d)

Fresenius Medical Care; Bad Homburg vor der Höhe; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Career development

Innovative culture

Global team

Global benefits

Job summary

Fresenius Medical Care in Germany is seeking a Quality Engineer I to ensure product quality, regulatory compliance, and process effectiveness across manufacturing operations.

The role will support quality improvement initiatives, investigate quality issues, drive NCCAPA activities, support validation programs, and collaborate with R&D, Risk Management, Manufacturing Operations, Engineering, Supply Chain, and Regulatory Affairs to ensure safe and compliant products.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 2–3 years of experience in a Quality Engineering role within medical devices.
• Experience with ISO 13485 environment.
• Knowledge of EU MDR and FDA medical device regulations.
• Strong organizational and project management skills.
• Understanding of Design Controls and Risk Management.
• Experience with CAPA, NC, change control, and complaint handling.
• Knowledge of statistical analysis and quality tools.
• Familiarity with process validation and qualification activities.
• Proficiency in Microsoft Office and eQMS.
• English language proficiency (written & spoken).
• Six Sigma Yellow/Green Belt is a plus.
• Willingness to travel.
• Ability to work in cross-functional teams.
• Analytical and problem-solving skills.

Responsibilities

• Support QMS implementation and maintenance per ISO 13485 and EU MDR.
• Investigate nonconformities and drive CAPA actions.
• Lead root cause investigations and verify CAPA effectiveness.
• Execute Periodic Validation Review.
• Analyze data and KPI trends to identify improvements.
• Support Risk Management processes.
• Drive operational excellence projects.
• Lead inter-phase/system complaint investigations.
• Execute Quality Plans for improvements or transitions.
• Promote a culture of quality across the organization.
• Support other QMS activities as directed by supervisor.

Skills

Quality engineering

Regulatory compliance

Project management

Statistical analysis

Quality tools

Process validation

Cross-functional teamwork

Analytical skills

English proficiency

Travel willingness

Education

Engineering degree

Tools

Microsoft Office

eQMS

Job description

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.

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

The Quality Engineer I is responsible for ensuring product quality, process effectiveness, and regulatory compliance throughout manufacturing operations. The role supports quality improvement initiatives, investigates quality issues, drives NCCAPA activities, supports validation programs, and partners with R&D, Risk Management, Manufacturing Operations, Engineering, Supply Chain, and Regulatory Affairs to ensure consistent production of safe and compliant products.

Tasks & Responsibilities:

• Support the implementation, maintenance and continuous improvement of the QMS in compliance with applicable standards and regulations such as ISO 13485 and EU MDR.
• Investigate manufacturing nonconformities and implement corrective actions through the NCCAPA system.
• Lead Root Cause (RCA) Investigations using structured methodologies and verification of effectiveness of the CAPA plans.
• Execute Periodic Validation Review.
• Perform Data Analysis, Trending and monitoring of KPIs for the manufacturing processes and products, identify improvement opportunities, to ensure product quality and compliance.
• Support Risk Management and Risk Assessment process.
• Support operational excellence initiatives, by executing and owning improvement projects.
• Lead and execute Inter phase/ system complaint investigations.
• Execute Quality Plans for improvement or system transitions.
• Promote a culture of quality throughout the organization.
• Support any other QMS related activities as instructed by direct supervisor.

Your Profile:

• Bachelor’s degree in Engineering, Quality Management, Biomedical Engineering, Industrial Engineering, Chemical Engineering or related technical discipline.
• 2-3 years of experience in a Quality Engineering role or similar within the medical device industry.

• Experience with non-active medical devices is preferred.

• Experience working within an ISO 13485-certified environment.

• Knowledge of EU MDR and FDA medical device regulations.
• Strong organizational and project management skills.

• Good understanding of Design Controls and Risk Management.

• Experience with CAPA, NC, change control, and complaint handling processes.

• Knowledge of statistical analysis and quality tools.

• Familiarity with process validation and qualification activities.

• Proficiency in Microsoft Office and electronic Quality Management Systems.
• Professional proficiency in English language (written and spoken) is required.
• Six Sigma Yellow or Green Belt is nice to have.
• Willingness to travel.

• Ability to work in cross-functional teams.

• Analytical and problem-solving skills.

Our Offer for you:

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