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.