Quality Engineer

At Ypsomed, we are shaping the future of medical technology together - with the goal of sustainably improving the quality of life for people with chronic diseases. We promote an open and inclusive corporate culture in which diversity is valued and new perspectives are welcome. Our employees take responsibility, work interdisciplinary, and develop innovative solutions with real social added value. In this responsible position, you will ensure that our products and processes comply with the applicable quality and regulatory requirements. In doing so, you will 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 in accordance with 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 framework 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 Why Ypsomed – making the treatment of chronic diseases possible The Ypsomed Group's more than 2200 employees worldwide develop and produce injection and infusion systems for self-medication. We are a successful, rapidly growing, family-run company with headquarters in Burgdorf (CH) and various production sites and subsidiaries worldwide. With our market-leading products and solutions, we enable people all over the world to self-treat. Despite chronic diseases such as diabetes, obesity, or certain types of, they thereby receive the greatest possible freedom. Contact Annina Workforce Acquisition & Engagement Partner Your future place of work Burgdorf Quality Engineer At Ypsomed, we are shaping the future of medical technology together - with the goal of sustainably improving the quality of life for people with chronic diseases. We promote an open and inclusive corporate culture in which diversity is valued and new perspectives are welcome. Our employees take responsibility, work interdisciplinary, and develop innovative solutions with real social added value. In this responsible position, you will ensure that our products and processes comply with the applicable quality and regulatory requirements. In doing so, you will 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 in accordance with 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 framework 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 Why Ypsomed – making the treatment of chronic diseases possible The Ypsomed Group's more than 2200 employees worldwide develop and produce injection and infusion systems for self-medication. We are a successful, rapidly growing, family-run company with headquarters in Burgdorf (CH) and various production sites and subsidiaries worldwide. With our market-leading products and solutions, we enable people all over the world to self-treat. Despite chronic diseases such as diabetes, obesity, or certain types of, they thereby receive the greatest possib