The posting
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.



