Quality Manager - MedTech

Michael Page International (Switzerland) SA; Lausanne; Vor Ort; CHF 180.000 - 230.000; Vollzeit

Zusammenfassung

Michael Page International (Switzerland) SA is seeking a Lead Quality Operations Leader in Lausanne to guide quality across internal manufacturing and external partners. You will assure ISO 13485 compliance, drive CAPA and risk management, and oversee teams of Quality Engineers and Technicians.

This role collaborates cross-functionally with supply chain, manufacturing, and R&D to ensure high-quality product releases.

Qualifikationen

• Master’s degree in engineering, life sciences or related technical field.
• Extensive quality experience in the medical device industry.
• Proven leadership or people management experience.
• Strong knowledge of ISO 13485 and medical device regulations.
• Experience in supplier quality, CAPA, risk management, validation and change control.

Aufgaben

• Lead Quality Operations across internal manufacturing and external partners.
• Ensure compliance with ISO 13485, FDA requirements and quality regs.
• Develop and manage 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 activities.
• Review and approve quality docs and product release records.
• Manage supplier quality performance, audits and quality agreements.
• Lead supplier investigations and continuous improvement initiatives.
• Collaborate with Supply Chain, Procurement, Manufacturing, Engineering, and R&D.
• Act as final quality approver for product release activities.

Kenntnisse

Quality leadership

CAPA

Risk management

Supplier quality

Change control

Regulatory compliance

Stakeholder management

Communication

Team leadership

Ausbildung

Master’s degree in Engineering or Life Sciences

Tools

QMS

Jobbeschreibung

Company Snapshot

• Innovative medical technology company
• Startup environment

About Our Client

Our client is a fast-growing and innovative medical device company developing advanced technologies that transform patients' lives. The organization combines scientific excellence, operational rigor, and a strong commitment to improving healthcare outcomes.

Job Description

• Lead Quality Operations activities across internal manufacturing and external partners.
• Ensure compliance with ISO 13485, FDA requirements, and applicable quality regulations.
• Manage and develop a team of Quality Engineers and Quality Technicians.
• Drive quality processes including CAPA, deviations, non-conformances, change control, and risk management.
• Oversee incoming, in-process, and final product quality control activities.
• 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.

The Successful Applicant

• Master's degree in Engineering, Life Sciences, or a 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.

What's on Offer

• A key leadership position within an innovative healthcare company.
• Direct impact on quality strategy and operational performance.
• International and cross-functional exposure.
• Opportunity to contribute to meaningful technologies improving patients' quality of life.
• Competitive compensation package and long-term career opportunities.