Senior Quality Assurance Specialist, APAC

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

Job summary

Arthrex is seeking a Senior Quality Assurance Specialist for APAC to advance quality excellence across the Asia Pacific region. The role reports to the APAC Quality Assurance Senior Manager and drives QMS initiatives, audits, CAPA, and quality performance reporting in multiple APAC markets.

The ideal candidate has a Bachelor's in Mechanical/Biomedical/Biomechanical engineering with 5–8 years in medical device QA, and hands-on ISO 13485:2016 experience.

Qualifications

• 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.

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.

Skills

Quality Assurance

Audits

CAPA management

QMS administration

Regulatory compliance

Project management

Stakeholder management

Communication

Education

Bachelor's degree in Mechanical/ Biomedical/ Biomechanical Engineering

Related discipline

Job description

Senior Quality Assurance Specialist, APAC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.