Our company is a leading provider of innovative medical technology solutions. With our advanced technologies and services, we improve the quality of life of patients worldwide. Join our team at the Burgdorf site in Quality System (dedicated Audit Team) and shaping and maintaining world-class quality systems in a dynamic, life sciences environment as
Quality System Manager | 80 - 100%
Ref. No. 7737
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
Serve as the main point of contact for customers in planning, executing, and following up on customer audits
Independently manage the internal coordination of customer audits, lead the front office during audits, and support post-audit activities
Take charge of or support front and back-office activities during regulatory authority audits
Representing IT & CSV topics during both customer and authority audits
Conduct root cause analyses and develop action plans as part of the internal deviation management system
Review and approve internal process instructions
Act as an internal contact person for quality-related topics across departments
Your profile
Degree in technical, scientific, or medical discipline, with additional qualifications in quality management
Several years of hands-on experience in quality management, ideally in the life sciences industry (e.g., medical devices, pharmaceuticals, biotechnology)
Strong knowledge of relevant regulatory standards: ISO 13485:2016, EU-MDR, MDSAP, 21 CFR 820. Familiarity with ISO/IEC 27001:2022 is a plus
Fluency in English is required; good German skills or a willingness to learn German is an advantage
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.
