Quality System Manager Audit Services

At Ypsomed, we are shaping the future of medical technology together - with the aim of sustainably improving the quality of life for people with chronic conditions. We promote an open corporate culture in which diversity is valued, and new perspectives are welcome. Our employees take responsibility, work in an interdisciplinary manner and develop innovative solutions with real added value for society.

Join us and take ownership of our global Quality Management System (QMS) and audit landscape.
In this role, you will ensure compliance with international regulatory requirements, drive continuous improvement, and shape QMS standards across international sites.
You will act as a central interface between functions, authorities, and external partners, with the opportunity to further grow into a global expert role.

Quality System Manager Audit Services | 80 - 100%

Ref. No. 7944

Location: Solothurn, Burgdorf | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

Your main tasks

• Ensure compliance of QMS processes with applicable regulatory requirements (e.g. ISO 13485, EU MDR, QMSR, MDSAP and other relevant standards)
• Plan, coordinate, and manage external audits conducted by customers, regulatory authorities, and certification bodies
• Lead and conduct internal audits (as lead or co-auditor), including audit planning, documentation, audit program management, and KPI reporting
• Drive continuous improvement of QMS processes in close collaboration with global and local stakeholders
• Investigate audit findings and take ownership of defining and implementing effective corrective and preventive actions (CAPAs)
• Act as a trusted partner to business units by advising and training on QMS-related topics (e.g. IT, sustainability, change control, audit management, deviation management, documentation)
• Lead or contribute to strategic QMS projects, including certifications, implementation at new international sites, and expansion into new markets

Your profile

• A degree in engineering, life sciences, medicine, or a related field
• Knowledge of relevant regulatory requirements (e.g. ISO 13485, EU MDR, QMSR, MDSAP, GMP)
• Experience with QMS software (e.g. 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)

Ypsomed - making the treatment of chronic diseases possible

More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.

Contact

Heiko Sieger
Human Resources Expert Recruiting

+41 (0) 34 424 26 34

Your future place of work

Solothurn

Burgdorf