Specialist, Quality 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.