Specialist, Quality Management (Complaint Management)

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.