Quality Engineer

At Ypsomed, we shape the future of medical technology together - with the aim of sustainably improving the quality of life for people with chronic illnesses. We promote an open and inclusive corporate culture where diversity is valued and new perspectives are welcomed. Our employees take responsibility, work interdisciplinarily, and develop innovative solutions with genuine societal benefit.

In this responsible position, you ensure that our products and processes comply with applicable quality and regulatory requirements. You take on a wide range of tasks - from document approval to change controls to participation in audits.

Quality Engineer | 80 - 100%

Ref No. 8104

Workplace: Burgdorf | Hybrid

Your Main Tasks

• Responsibility for compliance with quality requirements for products, processes, and documentation within your area of responsibility
• Ensuring that products are manufactured according to applicable guidelines, specifications, and standards (including cGMP, GDocP, ISO 13485, CFR Part 820, and FDA Guidelines)
• Reviewing and approving manufacturing documents (e.g., work instructions, batch release)
• Reviewing and approving documents related to qualification and validation activities (e.g., IQ, OQ, PQ)
• Reviewing, approving, and closing changes and associated documents within your area of responsibility (Change Control)
• Leading and processing NC/CAPAs according to deviation management
• Participating in internal audits as well as customer, authority, and supplier audits

Your Profile

• Completed technical or scientific education (HF, FH or equivalent)
• Further training in quality management (Lean Six Sigma Green/Black Belt certification is an advantage)
• Experience with plastic injection moulding products in an industrial environment; experience in high-volume manufacturing is an advantage
• In-depth knowledge in quality assurance/cGMP as well as solid 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) and good English skills (B2) in spoken and written form

Why Ypsomed – Making the Treatment of Chronic Diseases Possible

The more than 2200 employees of the Ypsomed Group develop and produce injection and infusion systems for self-medication. We are a successful, rapidly growing, family-run company headquartered in Burgdorf (CH) with various production sites and subsidiaries worldwide. With our market-leading products and solutions, we enable people around the world to self-treat. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they thereby gain the greatest possible freedom.

Contact

Annina Kistler
Workforce Acquisition & Engagement Partner

Your Future Workplace

Burgdorf