Specialist, Quality Management

Key Purpose Support and maintain Quality Management, Environmental Management, and Workplace Safety & Health systems to ensure compliance with regulatory and ISO requirements, while driving quality improvement initiatives across the organization. Key Responsibilities • Maintain and improve Quality Management Systems (ISO 13485 & ISO 9001). • Conduct internal, supplier, and external quality audits. • Manage quality complaints, CAPAs, and post-market surveillance activities. • Coordinate change control, recalls, and field corrective actions. • Support ISO 14001 Environmental Management System and Workplace Safety & Health compliance. • Maintain quality documentation, SOPs, and document control processes. Requirements • Diploma/Degree in a relevant scientific or engineering discipline. • At least 2 years of Quality Assurance/Quality Management experience in healthcare, medical device, IVD, pharmaceutical, or other regulated industries. • Knowledge of ISO 13485, ISO 9001, and quality management systems. • Certified ISO Lead Auditor is an advantage. • Experience in complaint handling systems (e.g. TrackWise) and CSV is preferred. • Strong communication, organizational, and problem-solving skills.