QA & Sterility Assurance Lead

integralife; Freiburg; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

integralife in Switzerland is seeking an Associate Manager, Quality Assurance & Sterility Assurance to lead QA systems, nonconformance investigations, CAPA, and sterility programs for sterile medical devices. You will partner with Manufacturing, Validation, and Regulatory teams to ensure cGMP compliance and drive continuous improvement.

The role requires 5+ years in QA for medical devices or pharma, expertise in sterility assurance and sterilization technologies, and fluency in English and

Qualifikationen

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field.
• 5+ years of QA experience in medical devices, pharma, or biotech.
• Experience leading nonconformance investigations, CAPA, change control, and risk management.
• Expertise in sterility assurance for sterile medical devices, including sterilization validation and environmental monitoring.
• Knowledge of sterilization technologies such as EO, gamma, electron beam, and steam.
• Strong knowledge of ISO 13485, ISO 11135, ISO 11137, ISO 11737, FDA QSR, and EU MDR requirements.
• Experience supporting regulatory inspections and audits.
• Strong leadership, problem-solving, and communication skills.
• Fluent in French and English.

Aufgaben

• Oversee nonconformance management and CAPA programs.
• Provide QA oversight to manufacturing operations and collaborate with cross-functional teams.
• Lead sterility assurance programs and regulatory compliance activities.
• Mentor QA personnel and support internal/regulatory audits.
• Promote culture of quality and continuous improvement.

Kenntnisse

Quality Assurance leadership

Nonconformance investigations

CAPA

Sterility assurance

Regulatory compliance

Cross-functional collaboration

Bilingual English/French

Ausbildung

Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related field

Jobbeschreibung

integralife in Switzerland is seeking an Associate Manager, Quality Assurance & Sterility Assurance to lead QA systems, nonconformance investigations, CAPA, and sterility programs for sterile medical devices. You will partner with Manufacturing, Validation, and Regulatory teams to ensure cGMP compliance and drive continuous improvement.

The role requires 5+ years in QA for medical devices or pharma, expertise in sterility assurance and sterilization technologies, and fluency in English and