Quality Management System Executive
- Singapore
- Permanent
- Full-time
- 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.
- 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.