Quality Manager

About the role

The Quality Manager will be based in Singapore and will lead the design, implementation and stabilization of a robust Quality Management System (QMS) for ELAPAC. The role starts with establishing compliance for all products and later transitions into an Operations Management function to drive service excellence and scalability.

Key responsibilities

• Develop, implement and maintain a QMS aligned with ISO 13485:2016 and relevant regulatory requirements (FDA, EU MDR, APAC, LATAM, META).
• Document and enforce quality processes across the organization and its entities.
• Conduct regular QMS reviews, risk assessments and manage mitigation activities.
• Ensure suppliers and contract manufacturers meet regulatory and quality standards.
• Oversee preparation and maintenance of technical documentation for all products.
• Act as the primary interface with regulatory and certification bodies.
• Lead day‑to‑day operations, cross‑functional coordination and capacity planning once the QMS is established.

Required profile

• Bachelor’s degree in engineering, Quality Management or related field (Master’s preferred).
• Minimum 4 years of quality management experience in the medical device industry.
• Proven experience with ISO 13485:2016 and other medical device regulations.
• Certifications such as Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) are a plus.
• Fluent in English and Chinese.

Required skills

• ISO 13485:2016 implementation
• Risk assessment and mitigation
• Regulatory compliance (FDA, EU MDR, APAC, LATAM, META)
• Supplier compliance management
• Quality Management System (QMS) development