Quality Assurance (QA) Specialist, East Asia
Core
Support the implementation and maintenance of the East Asia Quality Management System (QMS) and ensure compliance with corporate and local regulatory requirements.
Role type
Quality Assurance Specialist
Builds
Quality Management System (QMS) compliance and continuous improvement activities
Domain
Medical device / Healthcare / Pharmaceutical
Deliverable
dashboards & analysis
Required skills
Quality management systems knowledge, Regulatory reporting, Document control, KPI monitoring, Audit preparation, Product complaint management, Field safety corrective actions
Preferred skills
Medical device industry experience, ISO 13485 knowledge, GDPMDS knowledge, Cross-cultural collaboration
Responsibilities
Support QMS implementation and maintenance, Manage product complaints and field safety actions, Support regulatory reporting, Monitor quality KPIs, Prepare for internal and external audits, Collaborate with cross-functional teams
Seniority
Individual Contributor