Manager, Quality Systems

About the role

The Manager, Quality Systems leads the Quality Improvement and technical work unit, ensuring that quality system improvement strategies are implemented in compliance with applicable laws and regulations. This role oversees recruitment, performance management, and provides guidance on operational policy changes while acting as the primary contact for change leaders and R&D subject‑matter experts.

Key responsibilities

• Direct and supervise quality improvement projects, calibration, and preventive maintenance activities.
• Monitor quality system performance, set goals, and prioritize ECOs across manufacturing sites.
• Review and approve SOP changes, IT requirements, and CAPA investigations.
• Support external audits (FDA, ISO 13485, MDSAP) and manage risk assessments for product/process changes.
• Lead people development, vacation and overtime administration for exempt staff.

Required profile

• Six or more years of experience in quality engineering, preferably in the medical device industry.
• At least two years leading a quality or technical team.
• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Engineering).
• Fully bilingual with strong oral and technical written communication skills.

Required skills

• Knowledge of quality system regulations for medical devices and pharmaceuticals.
• Project management and change‑control expertise.
• Risk management and statistical analysis tools.
• Experience with metrology equipment.
• Proficiency in Microsoft Excel, Word, PowerPoint and quality documentation systems.