Quality Manager - MedTech in Lausanne

Overview

In this role you lead Quality Operations for internal manufacturing and external partners, ensuring ISO 13485 and FDA compliance. You will manage a Quality team and drive CAPA, risk management, and supplier quality initiatives to sustain high product quality. You will collaborate across Supply Chain, Manufacturing, Engineering, and R&D to release safe, compliant products and continuously improve quality performance. This is a leadership opportunity with international exposure in a fast-growing healthcare company.

Leistungen / Benefits

• competitive compensation package
• long-term career opportunities

Verantwortungsbereiche

• Lead Quality Operations across internal manufacturing and external partners
• Ensure compliance with ISO 13485, FDA requirements, and applicable quality regs
• Manage and develop a team of Quality Engineers and Technicians
• Drive CAPA, deviations, non-conformances, change control, and risk management
• Oversee incoming, in-process, and final product quality control
• Review and approve quality documentation and product release records
• Manage supplier quality performance, audits, qualifications, and quality agreements
• Lead supplier investigations and continuous improvement initiatives
• Collaborate with Supply Chain, Procurement, Manufacturing, Engineering, and R&D teams
• Act as final quality approver for product release activities

Zentrale Anforderungen

• Master's degree in Engineering, Life Sciences, or related technical discipline
• Extensive experience in Quality within the medical device industry
• Previous leadership or people management experience
• Strong knowledge of ISO 13485 and medical device regulations
• Proven experience in supplier quality, CAPA, risk management, validation, and change control
• Excellent communication, leadership, and stakeholder management skills
• Fluent in English

• communication
• leadership
• stakeholder management
• ISO 13485
• CAPA
• risk management