Senior Quality Assurance Specialist, APAC

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

Join Arthrex and play a key role in advancing quality excellence across the Asia Pacific region.

Reporting to the APAC Quality Assurance Senior Manager, you will support and drive Quality Management System (QMS) initiatives, continuous improvement projects, compliance activities, audits, CAPA management, and quality performance reporting across multiple APAC markets.

This role is ideal for an experienced Quality professional who is passionate about medical devices, regulatory compliance, and partnering with regional teams to strengthen quality systems and operational effectiveness.

Key Responsibilities:-

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

What We're Looking For:-

• Bachelor's Degree in Mechanical, Biomechanical, Biomedical Engineering, or a related discipline.
• 5-8 years of experience in Quality Assurance within the medical device industry.
• Hands-on experience with ISO 13485:2016 implementation and maintenance.
• Strong knowledge of Singapore HSA regulations and medical device regulations across APAC.
• Proven experience in audits, CAPA management, QMS administration, and continuous improvement initiatives.
• Excellent project management, communication, and stakeholder management skills.
• Experience with orthopedic products or medical device manufacturing is highly advantageous.

Why Join Arthrex?

• Opportunity to work with a global leader in orthopedic medical devices.
• Regional exposure across multiple APAC markets.
• Collaborative and innovative work environment.
• Be part of meaningful projects that contribute to improving patient outcomes worldwide.