Quality Engineer | 80 - 100%

At Ypsomed, we jointly shape the future of medical technology - with the goal of sustainably improving the quality of life for people with chronic illnesses. We promote an open and inclusive corporate culture in which diversity is valued and new perspectives are welcome. Our employees take on responsibility, work interdisciplinary, and develop innovative solutions with real social added value. In this responsible position, you ensure that our products and processes comply with the applicable quality and regulatory requirements. In doing so, you undertake a wide range of tasks - from document release and change controls to participation in audits. Quality Engineer | 80 - 100% # Ref-Nr. 8104 Work location: Burgdorf  | Hybrid Your main tasks ### • Responsibility for compliance with quality requirements for products, processes, and documentation within the area of responsibility • Ensuring that products are manufactured according to the applicable guidelines, specifications, and standards (including cGMP, GDocP, ISO 13485, CFR Part 820, and FDA Guidelines) • Reviewing and releasing manufacturing documents (e.g., work instructions, batch release) • Reviewing and releasing documents within the scope of qualification and validation activities (e.g., IQ, OQ, PQ) • Reviewing, releasing, and closing changes and associated documents within the area of responsibility (Change Control) • Leading and processing NC/CAPAs according to deviation management • Participation in internal audits as well as customer, authority, and supplier audits Your profile ### • Completed technical or scientific education (HF, FH, or comparable) • Further training in the field of quality management (Lean Six Sigma Green/Black Belt certification is an advantage) • Experience with plastic injection molded products in an industrial environment, experience in high-volume manufacturing is an advantage • In-depth knowledge in the field of quality assurance/cGMP as well as sound knowledge of quality and problem-solving methods (e.g., 8D, 5Why, Ishikawa, PDCA, DMAIC, FMEA, SPC-) • Experience in risk-based decision making • Very good German (C1) as well as good English skills (B2) in speaking and writing