Senior Quality Systems Specialist
Core
Lead implementation, maintenance, and continuous improvement of Quality Management Systems (QMS) for medical devices, ensuring compliance with ISO 13485 and Singapore HSA regulations.
Role type
Senior Quality Systems Specialist
Builds
ISO 13485-based QMS and GDP/GDPMDS certified quality processes
Domain
Medical device industry + Quality Management Systems
Required skills
ISO 13485 QMS implementation, Singapore HSA regulatory compliance, GDP/GDPMDS certification management, audit management (internal, supplier, external), CAPA/deviation/non-conformance/complaint investigation, stakeholder management with regulatory authorities
Preferred skills
Gap assessment and remediation, quality documentation management (SOPs, work instructions), quality training delivery
Technologies
ISO 13485, GDPMDS, Singapore HSA regulations
Responsibilities
Lead QMS implementation and continuous improvement, ensure regulatory compliance, drive GDP/GDPMDS certification readiness, conduct gap assessments, manage quality documentation, lead internal and supplier audits, support regulatory inspections
Seniority
Senior, hands-on IC