APAC Quality Assurance Lead – Medical Devices

Arthrex APAC; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Arthrex APAC, based in Singapore, is seeking an experienced Quality professional to support APAC QMS initiatives and continuous improvement across markets.

Reporting to the APAC Quality Assurance Senior Manager, you will drive audits, CAPA management, quality metrics reporting, and regulatory compliance with ISO 13485:2016 and Singapore HSA requirements, partnering with regional teams to strengthen quality systems and operational effectiveness.

Qualifications

• Bachelor's degree in a related engineering field.
• 5–8 years of Quality Assurance experience in medical devices.
• Hands-on ISO 13485:2016 implementation experience.
• Strong knowledge of Singapore HSA and APAC medical device regulations.
• Experience with audits, CAPA management, QMS administration.
• Excellent project management and stakeholder communication.

Responsibilities

• Support and lead APAC quality improvement and QMS harmonization initiatives.
• Drive compliance with ISO 13485:2016 and regulatory requirements across APAC.
• Manage audits, non-conformances, CAPAs, and quality metrics reporting.
• Partner with cross-functional and regional teams on quality projects.
• Identify quality system risks and communicate recommendations to management.
• Support internal audits and business growth through effective quality oversight.

Skills

Quality Assurance

Regulatory Compliance

Project Management

Stakeholder Management

Education

Bachelor's Degree in Mechanical, Biomechanical, Biomedical Engineering, or related

Tools

Document Control Systems

Job description

Arthrex APAC, based in Singapore, is seeking an experienced Quality professional to support APAC QMS initiatives and continuous improvement across markets.

Reporting to the APAC Quality Assurance Senior Manager, you will drive audits, CAPA management, quality metrics reporting, and regulatory compliance with ISO 13485:2016 and Singapore HSA requirements, partnering with regional teams to strengthen quality systems and operational effectiveness.