As we establish Ypsomed Diabetes Care AG (YDC AG) as an independent med-tech company specializing in diabetes treatment through advanced insulin pump systems, the Head of Quality will play a pivotal role in defining and driving our quality standards and systems.

Head of Quality YDC | 100%

Ref. No. 7312

Location: 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

• Lead the Quality organization (approx. 30 HC) at Ypsomed Diabetes Care AG, covering QMS Management, Quality Assurance, Quality Control, and Supplier Quality Assurance
• Establish and implement a quality vision aligned with the company's goals, driving a quality-focused culture and policy throughout Ypsomed Diabetes Care AG
• Build and lead a Quality team for the newly founded Ypsomed Diabetes Care AG, setting and achieving Quality objectives
• Drive transformation towards an independent, scalable QMS for Ypsomed Diabetes Care AG post spin-off, ensuring compliance with key quality regulations (EU MDR, MDSAP, ISO 13485, 21 CFR 820)
• Define and implement Quality tools and data strategies to support compliance and scalability
• Partner with business functions to support future growth, and train the organization on regulatory and quality processes to enhance compliance and process efficiency
• Act as the Quality Management Representative, overseeing Quality planning, audits (internal and external), CAPA, change & document management, and QMS training

Your profile

• University degree in engineering or business management (MBA or equivalent) with additional education in quality management
• Extensive knowledge of medical device standards and regulations (ISO 13485, EU MDR, 21 CFR 820, IEC 62304, ISO 14971)
• 15+ years in the medical device or regulated life sciences industry, with at least 10 years in a senior leadership role
• Charismatic and empathetic team leader with a strong record in building high-performing, cross-functional teams and fostering a quality-focused culture
• Proven ability to transform Quality systems, covering people, processes, governance, systems, and data, and position quality as a compliance and performance partner
• Strong business acumen with experience in digital QMS implementation, process architecture, and data architecture
• Proficient in English and German; effective communicator at all levels with intercultural awareness and demonstrated skills in problem-solving and change management

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

Alain Rusconi
Human Resources Expert Recruiting

+41 (0) 34 424 28 64

Your future place of work

Solothurn