Join a team that shapes the future of medical technology and helps improve the lives of people with chronic conditions. You take ownership of our global Quality Management System (QMS) and audit landscape, ensuring compliance with international standards and driving continuous improvement across our sites.

• Ensure QMS processes meet international regulatory requirements, such as ISO 13485, EU MDR, QMSR, MDSAP, and other standards
• Plan, coordinate, and manage external audits from customers, regulatory authorities, and certification bodies
• Lead and conduct internal audits, including planning, documentation, audit program management, and KPI reporting
• Drive continuous improvement of QMS processes with global and local stakeholders
• Investigate audit findings and take responsibility for defining and implementing corrective and preventive actions (CAPAs)
• Advise and train business units on QMS topics, including IT, sustainability, change control, audit management, deviation management, and documentation
• Lead or contribute to strategic QMS projects, such as certifications, implementation at new international sites, and expansion into new markets

• Degree in engineering, life sciences, medicine, or a related field
• Knowledge of regulatory requirements like ISO 13485, EU MDR, QMSR, MDSAP, and GMP
• Experience with QMS software such as TrackWise, SAP, or similar systems is an advantage
• Strong stakeholder management and communication skills
• Experience working with regulatory authorities or notified bodies is a plus
• Fluent in German and English, both written and spoken (C1 level)