The posting
Key Purpose
Support and maintain Quality Management and Environmental Management Systems by overseeing complaint handling, post-market activities, quality performance monitoring, environmental compliance, and audit support. Ensure compliance with regulatory requirements while driving continuous improvement across quality processes.
Key Responsibilities
- Manage customer complaints, investigations, and complaint resolution activities for medical devices.
- Coordinate and support post-market activities, including Field Corrective Actions (FCA), recalls, and regulatory reporting.
- Monitor and maintain risk management activities related to complaint handling and post-market surveillance.
- Track, analyze, and report quality KPIs, objectives, and performance metrics.
- Support Environmental Management System (EMS) initiatives, environmental reporting, and ECO Track management.
- Assist with internal and external audits, including audit preparation, documentation, and follow-up actions.
- Support regional quality meetings through data consolidation, reporting, and presentation preparation.
- Collaborate with cross-functional stakeholders to drive compliance and continuous improvement initiatives.
Requirements
- Minimum 2 years of Quality Assurance experience within the medical device industry.
- Certified Internal Auditor for ISO 13485, ISO 9001, and/or ISO 14001 preferred.
- Knowledge of ISO 13485, ISO 9001, ISO 14001, ISO 27001, and Workplace Safety & Health (WSH) requirements.
- Experience in complaint handling, post-market surveillance, and quality management systems.
- Experience in data analysis, KPI monitoring, and quality reporting.
- Proficient in Microsoft Office applications.
- Strong communication, stakeholder management, and problem-solving skills.



