Responsible for maintaining the Quality Management System (QMS) in compliance with Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance) and other regulatory requirements
Job Summary
Responsible for maintaining the Quality Management System (QMS) in compliance with Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance) and other regulatory requirements.
Manage NCR processes, monitor process operations, collect and analyze data for regular reviews, and collaborate with cross-functional members to prepare materials.
Assist in scheduling, planning, and conducting effective internal and external audit programs, and manage documentation and training.
Matching Summary
Responsible for maintaining the Quality Management System (QMS) in compliance with Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance) and other regulatory requirements.
Skills & Requirements
Must-have
Quality Management System maintenance
Regulatory compliance
Non-Conformance Report (NCR) process management
Supplier management
Internal and external audit support
Nice-to-have
Proactive improvement suggestions
Adaptability to changing requirements
Collaboration with global teams
Key Requirements
10+ years of experience in medical device quality systems
3-5 years of domestic quality operations experience
Deep understanding of Pharmaceutical and Medical Device Law (PMD Act)
Experience with regulatory authority reporting
Experience presenting quality systems and audit response