Job Responsibilities:

1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.

2. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.

3. Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.

4. Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.

5. Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.

6. Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.

7. Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.

8. Support supplier audits and evaluations to ensure adherence to quality standards.

9. Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

Job Requirements

1. Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.

2. Minimum of 2 years of experience in quality management or related roles within the medical device or IVD industry.

3. Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore’s HSA regulations.

4. Skills:

I. Strong understanding of quality management principles and regulatory requirements.

II. Excellent organizational and documentation skills.

III. Strong analytical and problem-solving skills.

IV. Effective communication and teamwork abilities.

VI. Ability to work independently and manage multiple tasks efficiently.

5. Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.