Quality Operations Leader – Med Tech & Compliance

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

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.