Hybrid Quality Engineer Autoinjectors (Burgdorf, CH) bei Ypsomed AG

Your main tasks

• Act as Quality Assurance (design assurance) representative in development projects for platforms and product variants, as well as in Life Cycle Management activities
• Ensure compliant documentation in the projects and processes acc. to applicable standards, regulations and customer requirements
• Drive the resolution of quality issues through effective collaboration across all organizational levels and functions
• Collaborate in projects and sub-projects for optimisation, harmonization and further development of processes
• Monitor and analyze quality performance indicators and ensure transparent reporting to relevant stakeholders
• Perform investigations, prepare quality reports and apply statistical methods to support data-driven decision-making
• Support quality-related communication with customers and actively participate in internal, customer, and regulatory audits

Your profile

• Technical background, ideally in mechanical engineering, polymer engineering or automation, combined with a degree in the natural sciences (FH, ETH, or university) or equivalent relevant professional experience
• Minimum two years of experience in a comparable role in the MedTech sector or comparable industry
• Strong analytical and methodological skills, with a structured and goal-oriented approach to problem-solving
• Ensuring compliance with applicable standards and regulatory requirements (e.g., ISO 13485:2016)
• Proficiency in ERP systems (e.g., SAP), with familiarity in tools such as TrackWise, JIRA, Power BI, SAP Analytics Cloud or AI-driven applications
• Good communication and language skills in writing and orally (German and English B2 or higher)