APAC Quality Assurance Lead – Medical Devices

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

Benefits offered by this job

Global leader in orthopedic devices

Regional exposure across APAC

Collaborative work environment

Job summary

Arthrex, Inc. is seeking an experienced Quality professional to support APAC quality initiatives and QMS harmonization across markets in Asia Pacific.

Reporting to the APAC Quality Assurance Senior Manager, you will drive compliance, CAPA, audits, and quality performance reporting to strengthen patient safety and regulatory readiness. The role emphasizes collaboration with cross-functional regional teams, hands-on ISO 13485 implementation, and continuous improvement to optimize quality systems

Qualifications

• 5–8 years of experience in Quality Assurance within medical devices.
• Hands-on ISO 13485:2016 implementation and maintenance.
• Strong knowledge of Singapore HSA regulations and APAC medical device regs.
• Experience with audits, CAPA management, and QMS administration.
• Proven ability to drive continuous improvement and cross-functional projects.

Responsibilities

• Support and lead APAC quality improvement and QMS harmonization.
• Ensure compliance with ISO 13485:2016 and regulatory requirements across APAC.
• Manage audits, non-conformances, CAPA, and quality metrics reporting.
• Collaborate with regional teams to implement quality and operational improvements.
• Identify quality system risks and communicate recommendations to management.
• Support internal audits and business growth through quality oversight.

Skills

Quality Assurance

ISO 13485

Regulatory compliance

Audits

CAPA

QMS administration

Project management

Stakeholder mgmt

Education

Bachelor's degree in Mechanical/ Biomedical Engineering

Job description

Arthrex, Inc. is seeking an experienced Quality professional to support APAC quality initiatives and QMS harmonization across markets in Asia Pacific.

Reporting to the APAC Quality Assurance Senior Manager, you will drive compliance, CAPA, audits, and quality performance reporting to strengthen patient safety and regulatory readiness. The role emphasizes collaboration with cross-functional regional teams, hands-on ISO 13485 implementation, and continuous improvement to optimize quality systems