Quality Engineer (m/f/d)

CH01 CHE Fresenius Medical Care (Schweiz) AG; Bad Homburg vor der Höhe; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Career development

Innovative culture

Global corporation

Collaborative environment

Job summary

Fresenius Medical Care in Germany is seeking a Quality Engineer I to ensure product quality, process effectiveness and regulatory compliance across manufacturing operations. You will support quality initiatives, investigations, and CAPA, collaborating with R&D, Risk Management, Manufacturing, Engineering, Supply Chain and Regulatory Affairs to ensure safe, compliant production.

The role requires a Bachelor’s in Engineering or related field, 2–3 years in a quality engineering role in the medical

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 2-3 years in a Quality Engineering role in medical devices.
• Experience with ISO 13485 environment and EU MDR knowledge.

Responsibilities

• Support implementation and maintenance of the QMS in line with ISO 13485 and EU MDR.
• Investigate nonconformities and drive CAPA actions.
• Lead Root Cause investigations and verify CAPA effectiveness.
• Perform data analysis, KPI monitoring and trend analysis.

Skills

Quality Engineering

ISO 13485

EU MDR

CAPA

Risk Management

Design Controls

Statistical Analysis

Process Validation

Project Management

Cross-functional teamwork

Education

Bachelor’s degree in Engineering

Biomed / Medical Devices background

Tools

QMS Software

Excel

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.

Quality Engineer I

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 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
• Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world’s leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.