APAC Quality Assurance Lead – QMS & Compliance

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

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.