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...