CAPA Expert (mfd)

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 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

Our site in Schweinfurt plays an important part of our global production of dialysis medical devices. More than 1400 employees contribute their expertise and dedication to ensuring our products meet the highest quality standardsabout one-third of them working in research and development. Since 2019 Schweinfurt has also a technology center spanning approximately 8000 square meters. Around 220 specialists from various disciplines collaborate here to advance the development of our dialysis devices. We manufacture medical devices specifically designed for hemodialysis (HD) peritoneal dialysis (PD) and acute care treatments. Join this team and play a significant role in the continued development and improvement of dialysis therapies worldwide.

As a CAPA Expert (f/m/d) your role will focus on

Your Responsibilities:

• Lead and manage CAPA investigations ensuring compliance effectiveness and timely execution.
• Apply structured problem-solving methods to identify root causes and define corrective and preventive actions.
• Act as CAPA Lead for assigned cases and collaborate cross-functionally with Quality Systems and operational teams.
• Perform Quality Approver activities for CAPAs and NCs in alignment with regulatory and internal requirements.
• Drive CAPA/NC reporting data analysis and trend evaluations presenting outcomes to the CAPA Review Board and management.
• Support audits inspections and process improvements including implementation of new CAPA tools and methods.
• Provide training mentorship and guidance on CAPA and NC processes across multiple sites.

Your Profile:

• Bachelors degree in Life Sciences Engineering Quality Management or a related technical field.
• Minimum 3 years of CAPA management experience in the MedTech industry in an international environment.
• Strong knowledge of ISOCFR Part 820.100 EU MDR and GDP requirements.
• Proven analytical and problem-solving abilities including experience with structured RCA methodologies.
• Demonstrated success in cross-functional collaboration and influencing stakeholders.
• Strong organizational communication and project management skills with high attention to detail.
• Fluent in German and English; willingness to travel when required.

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert (m/f/d) 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