Senior Quality Systems Specialist- Singapore based remote role /
Core
Implement, maintain, and improve ISO 13485-based Quality Management Systems for medical device commercialization in Singapore and Southeast Asia.
Role type
Senior Quality Systems Specialist
Builds
Regional quality system activities and certification compliance
Domain
Medical device industry / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
ISO 13485 implementation, Singapore HSA regulations, GDP/GDPMDS certification, regulatory authority coordination, quality documentation management, cross-functional collaboration
Preferred skills
Malaysia medical device regulatory experience
Technologies
Microsoft Office
Responsibilities
Implement and maintain ISO 13485 QMS, lead GDP/GDPMDS certification, ensure HSA compliance, coordinate with certification bodies, prepare audit records, support regional quality activities
Seniority
Senior, hands-on IC
