Quality Engineer (m/w/d) – Validation, FMEA & Regulatory Compliance, Medical Devices

Becton, Dickinson (BD) is a leading global medical‑technology company whose purpose is to advance health worldwide. The Quality Engineer (m/w/d) will be based in Wangs, Switzerland, and will support validation, risk management and quality‑assurance work within a highly regulated medical‑device manufacturing setting. Each day the engineer will help keep commercial production aligned with internal procedures, FDA rules and international standards such as ISO 13485, EU MDR and ASTM. Responsibilities include creating and approving validation protocols, carrying out IQ, OQ and PQ activities, reviewing test‑method reports, and collaborating with manufacturing engineering on design, production and user FMEAs. The role also involves maintaining risk‑management documentation per ISO 14971/24971, leading CAPA efforts, performing statistical analyses with tools like Minitab and DOE, and supporting the broader manufacturing engineering team on quality‑related tasks. Candidates must hold a bachelor’s degree in an engineering discipline—preferably mechanical, process, materials science, chemical or pharmaceutical engineering—and have practical experience in the medical‑device sector or a comparable regulated environment. Required knowledge includes global MedTech standards (ISO 13485, ISO 14971/24971, EU MDR), hands‑on validation work (IQ/OQ/PQ), statistical tools and CAPA processes. Fluency in both German and English, strong analytical and problem‑solving abilities, a meticulous, process‑oriented approach, proficiency with MS Office, and familiarity with DOE and Minitab are essential, as is a collaborative attitude toward multidisciplinary, international teams. The position offers the chance to work in a state‑of‑the‑art MedTech facility, join a cross‑functional group where quality expertise directly influences patient outcomes, and develop within a culture that values precision, accountability and continuous improvement. Backgrounds in sterilization validation or quality and regulatory affairs are also welcomed.