Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements
Job Summary
Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements.
Define and implement processes which meet regulatory requirements pertaining to the selection, evaluation, and monitoring of suppliers.
Responsible for coaching, training and development of subordinates and identifies and manages continuous improvement projects.
Matching Summary
Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements.
Skills & Requirements
Must-have
Quality Management System
regulatory requirements
NCR process management
Supplier Management processes
internal and external Audit program
Document Control and Training system
Nice-to-have
Business Alignment
Fact-Based Decision Making
Tactical Thinking
Technical Credibility
fast-paced environment
managing multiple priorities
Key Requirements
BS degree in a related discipline
10+ years’ experience in medical device quality systems