Quality Assurance Manager – Freelance to Permanent (Lausanne)

About the role

We are partnering with a fast‑growing medical‑technology company in Lausanne that designs innovative therapeutic solutions. The organisation seeks a Quality Assurance Manager to own and evolve its Quality Management System (QMS), moving it from a solid foundation to a lean, robust, and scalable framework.

Key responsibilities

• Own, maintain and continuously improve the QMS.
• Design a lean QMS structure that supports rapid business growth.
• Plan, lead and execute internal audits and support external audits (customers, notified bodies, regulators).
• Review and approve technical documentation and technical files.
• Ensure ongoing compliance with ISO 13485, ISO 14971, IEC 62304 and applicable medical‑device regulations (e.g., EU MDR).
• Act as the primary quality authority for internal teams, external partners and regulatory bodies.
• Support CAPA, deviation handling, risk management and change‑control processes.
• Collaborate with engineering, operations and leadership to embed quality into daily activities.

Required profile

• Proven experience in a quality‑management role within medical devices, diagnostics or regulated life‑sciences.
• Strong knowledge of ISO 13485 and medical‑device regulatory frameworks (EU MDR).
• Hands‑on experience with technical file approval and audit management.
• Ability to work independently or build a quality structure in a small‑to‑mid‑size organisation.
• Excellent communication skills with the ability to influence technical and non‑technical stakeholders.

Required skills

• ISO 13485
• ISO 14971
• IEC 62304
• EU MDR (Medical Device Regulation)
• Technical file approval
• Audit management
• CAPA processes
• Risk management
• Change‑control procedures

What we offer

• High‑impact role with direct influence on company quality strategy.
• Opportunity to shape and modernise the QMS from the ground up.
• Freelance start with a clear pathway to permanent employment.
• Collaborative, product‑focused environment.
• Competitive compensation (CHF 100k – 120k per year).
• On‑site role in Lausanne with a hands‑on team culture.