Quality Management Specialist – Regulatory & Post‑Market

About the role

The Quality Management Specialist ensures compliance with regulatory and quality standards for the Robotic Assisted Surgery (RAS) business. This role oversees complaint handling, post‑market activities, risk management, and environmental compliance while supporting SAP quality performance and KPI reporting.

Key responsibilities

• Apply systematic problem‑solving to identify, prioritize, and resolve product quality issues and manage the shared complaint log.
• Coordinate with Clinical Specialists, Supply Chain, Warehouse, and Regulatory Affairs to handle defective units, event reporting, and authority communications.
• Execute field corrective actions, quarantine affected batches, and track progress with legal manufacturers and affiliates.
• Maintain risk registers for complaint management and post‑market activities.
• Support the Quality Management Representative in monitoring quality and environmental objectives, reporting KPIs, and ensuring alignment with EMS and ESG goals.
• Provide expertise on environmental regulations, manage data within the ECO tracking system, and assist in regional quality meetings.

Required profile

• Experience in complaint management and post‑market surveillance for medical devices.
• Knowledge of regulatory requirements and risk management processes.
• Familiarity with SAP quality performance metrics and KPI analysis.
• Understanding of environmental regulations and EMS/ESG frameworks.
• Ability to coordinate across clinical, supply chain, regulatory, and warehouse functions.

Required skills

• SAP
• SharePoint
• ECO tracking system
• Data analysis
• KPI monitoring
• Risk register management