Cluster Lead Quality and EHS Management Systems

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

Systems Quality & Regulatory (SQR) a global function within Care Enablement ensuring Fresenius Medical Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. The team supports market access innovation and patient safety by driving excellence across manufacturing and supply chain overseeing post-market surveillance and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Goal of function: The Cluster Lead - Quality and EHS Management Systems manages and oversees QMS across the assigned cluster ensuring consistent and effective implementation to support the business. The role manages Cluster Experts and acts as their deputy when required. As LMR for one or more countries the role ensures compliance implementation and continuous improvement of GMS QMS and EHS in line with global and local regulatory requirements and serves as the interface between global and local management across EMEA.

Your Responsibilities:

• Lead and develop the team ensuring performance management capability building prioritization and strong cross-functional collaboration
• Ensure effective implementation maintenance and continuous improvement of QMS and EHS systems across the cluster including compliance with certifications and regulations
• Oversee audit and inspection readiness monitor compliance via KPIs and audits and ensure timely closure of corrective and preventive actions (CAPAs) escalating risks when needed
• Adapt global requirements to local systems ensuring regulatory compliance and promoting a risk-based approach
• Evaluate and report on system performance lead management reviews maintain system data and act as interface to global functions and external bodies
• Manage implementation and updates of global and local directives including regulatory-specific requirements supported by gap and risk assessments
• Ensure effective coordination and completion of required training and compliance programs
• Drive continuous improvement through root cause analysis CAPA oversight and alignment with global and local stakeholders
• Oversee EHS regulatory monitoring compliance declarations purchasing-related aspects and communication with global EHS teams

Your Profile:

• Bachelors degree in a scientific or technical field (e.g. Engineering Bioengineering)
• 36 years of experience in QMS and EHS including multi-country exposure
• Minimum 3 years of people leadership in Healthcare/MedTech managing diverse teams
• Advanced training in GMS/QMS processes and governance
• Experience overseeing operations across multiple EMEA countries
• Strong knowledge of QMS and relevant regulatory requirements
• Fluent in English (written and spoken)
• Strong strategic and solution-oriented leader with proven coaching and teambuilding skills able to balance operational execution with people development; excels in independent work manages time and priorities effectively and communicates complex topics clearly while engaging diverse stakeholders
• Knowledge of ISO 9001 ISO 13485 and ISO 19011
• Understanding of internal and external QMS processes
• Flexible and willing to travel as needed

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