Quality & Sterility Assurance Lead

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

Zusammenfassung

Integra LifeSciences Switzerland Sàrl is seeking an Associate Manager, Quality Assurance - Sterility Assurance to lead quality systems for sterile medical device manufacturing. You will drive nonconformance investigations, CAPA, sterilization validation, and contamination control to ensure patient safety and regulatory compliance.

The role requires a strong background in sterility assurance, ISO/FDA/EU MDR knowledge, and the ability to mentor QA staff while coordinating with cross-functional

Qualifikationen

• Bachelor's degree in life sciences or engineering.
• 5+ years in Quality Assurance within medical devices, pharmaceutical, or biotech.
• Experience leading nonconformance investigations, CAPA, change control, and risk management.

Aufgaben

• Oversee nonconformance management and CAPA with root-cause analysis.
• Provide QA oversight to manufacturing operations and change controls.
• Lead sterility assurance programs and environmental monitoring.
• Coach QA team, support internal and regulatory audits.

Kenntnisse

QA leadership

Regulatory compliance

Communication

Languages: FR/EN

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

Integra LifeSciences Switzerland Sàrl is seeking an Associate Manager, Quality Assurance - Sterility Assurance to lead quality systems for sterile medical device manufacturing. You will drive nonconformance investigations, CAPA, sterilization validation, and contamination control to ensure patient safety and regulatory compliance.

The role requires a strong background in sterility assurance, ISO/FDA/EU MDR knowledge, and the ability to mentor QA staff while coordinating with cross-functional