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 process improvements and work with teams to enhance efficiency and effectiveness
Requirements
Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field
Minimum of 2 years of experience in quality management, regulatory affairs, or related roles within the medical device or IVD industry
Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations
Skills:
Strong understanding of quality management principles and regulatory requirements
Excellent organizational and documentation skills
Strong analytical and problem-solving skills
Effective communication and teamwork abilities
Ability to work independently and manage multiple tasks efficiently
Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications
