Quality Management System Executive

Key Responsibilities: Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance Prepare for and participate in internal and external audits, including regulatory inspections and customer audits Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management Assist in risk assessment and mitigation activities related to product quality and regulatory compliance Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness Support supplier audits and evaluations to ensure adherence to quality standards Identify opportunities for proces...