Quality Compliance Leader - Medical Devices

Integra LifeSciences; Le Locle; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Integra LifeSciences is seeking a Quality Compliance Manager in Switzerland to oversee the Quality Management System, CAPA, audits, document control, training, and complaint handling at the Le Locle site. The role ensures compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and other global standards.

You will lead a multidisciplinary team, drive continuous improvement, and coordinate health and safety, regulatory, and internal audits across functions to maintain patient safety and product

Qualifikationen

• Master’s degree in Life Sciences or related field.
• Excellent knowledge of medical device standards (ISO 13485, 21 CFR 820, EU MDR).
• Fluent English and French with strong communication skills.

Aufgaben

• Oversee Quality Management System activities including CAPA, audits, and document control.
• Lead complaint management, root cause analysis, and KPI reporting to ensure patient safety.
• Manage site CAPA process and coordinate cross-functional quality initiatives.
• Lead a multidisciplinary team of Quality Engineers and Technicians.
• Drive continuous improvement of quality systems and regulatory compliance.

Kenntnisse

Fluent English

Fluent French

Strong leadership

Analytical thinking

Ausbildung

Master's degree in Life Sciences

Jobbeschreibung

Integra LifeSciences is seeking a Quality Compliance Manager in Switzerland to oversee the Quality Management System, CAPA, audits, document control, training, and complaint handling at the Le Locle site. The role ensures compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and other global standards.

You will lead a multidisciplinary team, drive continuous improvement, and coordinate health and safety, regulatory, and internal audits across functions to maintain patient safety and product