Senior Quality Assurance Specialist – APAC

About the role

Arthrex is seeking a Senior Quality Assurance Specialist to lead quality excellence across the Asia Pacific region. Reporting to the APAC Quality Assurance Senior Manager, you will support QMS initiatives, continuous improvement projects, compliance activities, audits, CAPA management and quality performance reporting across multiple APAC markets.

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.

Required profile

• Bachelor’s degree in Mechanical, Biomechanical, Biomedical Engineering or related discipline.
• 5‑8 years of Quality Assurance experience in 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.

Required skills

• ISO 13485:2016 implementation and maintenance
• Singapore HSA regulatory knowledge
• APAC medical device regulatory expertise
• Audit management
• CAPA management
• QMS administration
• Continuous improvement methodologies

What we offer

• Opportunity to work with a global leader in orthopedic medical devices.
• Regional exposure across multiple APAC markets.
• Collaborative and innovative work environment.
• Participation in projects that improve patient outcomes worldwide.