Quality Compliance Lead — Medical Devices & CAPA

Integra-Lifesciences; Le Locle; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Integra LifeSciences is seeking a Quality Compliance Manager to oversee the QMS, CAPA, audits, and training across sites. You will manage complaint handling, KPI reporting, and regulatory activities to ensure patient safety and product quality.

The role requires leadership of Quality Engineers and Technicians, strong cross-functional collaboration, and fluency in English and French. ISO 13485 and MDR experience is essential.

Qualifikationen

• Master’s degree in Life Sciences required.
• Minimum 10 years of professional experience in medical device or pharmaceutical environments.
• Fluent in English and French with strong communication skills.
• Extensive knowledge of ISO 13485, 93/42/EEC, EU MDR, and 21 CFR Part 820.

Aufgaben

• Oversee complaint management including evaluation, investigation and trend analysis.
• Lead internal audits, maintain schedule and ensure regulatory alignment.
• Coordinate CAPA processes and drive corrective actions across sites.
• Support training, document control, and quality system enhancements.
• Guide health and safety, risk assessment and supplier quality programs.

Kenntnisse

Quality management

Regulatory compliance

Leadership

Communication

Ausbildung

Master's degree in Life Sciences

Tools

LMS

PLM

CAPA system

Jobbeschreibung

Integra LifeSciences is seeking a Quality Compliance Manager to oversee the QMS, CAPA, audits, and training across sites. You will manage complaint handling, KPI reporting, and regulatory activities to ensure patient safety and product quality.

The role requires leadership of Quality Engineers and Technicians, strong cross-functional collaboration, and fluency in English and French. ISO 13485 and MDR experience is essential.