Hybrid Quality System Manager (Burgdorf, CH) chez Ypsomed AG

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