Senior Specialist, Quality
Core
Ensuring product development integrity and safety through post-market surveillance, supplier management, and QMS performance analysis for medical devices.
Role type
Senior Specialist, Quality (Medical Devices)
Builds
Regulatory compliance for APAC markets, supplier performance dashboards, and continuous improvement projects.
Domain
Medical Devices / Quality Management Systems
Deliverable
dashboards & analysis
Required skills
Post-market surveillance, supplier management, QMS data analysis, regulatory compliance (ISO13485), cross-functional collaboration, continuous improvement implementation
Preferred skills
AI/IT software knowledge (Copilot studio, ERP), medical device industry experience
Technologies
IQVIA, MS Office Suite, Copilot studio, ERP
Responsibilities
Monitor and analyze customer complaint trends for post-market surveillance; Maintain Regional Supplier Management file and analyze supplier performance; Analyze QMS performance data for management reviews; Lead implementation of process modifications to resolve open issues; Execute assigned continuous improvement programs
Seniority
Senior, hands-on IC