Senior Quality Systems Specialist
Core
Lead the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS) for medical devices, ensuring compliance with Singapore HSA regulations and GDP/GDPMDS standards.
Role type
Senior Quality Systems Specialist
Builds
Certified and compliant medical device quality systems
Domain
Medical device industry, Regulatory compliance (Singapore HSA, GDP/GDPMDS)
Required skills
ISO 13485 QMS implementation, Singapore HSA regulatory compliance, GDP/GDPMDS certification, cross-functional collaboration, regulatory authority interaction, Microsoft Office
Preferred skills
Experience in Malaysia medical device market
Responsibilities
Lead quality system initiatives independently, guide organizations through certification and regulatory compliance activities, interact with certification and accreditation bodies
Seniority
Senior, hands-on IC