Quality Specialist (m/f/d) – Biotech Development

About the role

We are seeking a Quality Specialist to join a fast‑growing biotech development company in Urdorf. The role is hands‑on and supports projects from early concept through prototype, pilot series and production readiness, ensuring quality standards are met at every stage.

Key responsibilities

• Manage change requests, CAPAs and non‑conformities throughout the development lifecycle.
• Execute established workflows for biotech projects and act as the primary quality contact for project teams.
• Perform risk and hazard analyses, including FMEA, and conduct incoming inspections, in‑process controls and FATs.
• Coordinate and maintain project documentation, lead gate reviews and manage the electronic Document Management System (eDMS).
• Support supplier management implementation and improve deviation management processes.

Required profile

• Proven experience in Quality Management, preferably in biotech, pharma or med‑tech.
• Strong understanding of product development workflows from concept to production.
• Detail‑oriented, structured and proactive working style.
• Excellent communication skills and ability to collaborate in cross‑functional teams.
• Fluent in English; German is a plus.

Required skills

• FMEA
• eDMS

What we offer

• 4–6 month fixed‑term contract with the possibility of extension.
• Full‑time onsite position in a dynamic, innovative environment.