Leads the construction, maintenance, and improvement of internal quality system processes, focusing on the proper establishment, operation, and compliance of the quality management system
Job Summary
Leads the construction, maintenance, and improvement of internal quality system processes, focusing on the proper establishment, operation, and compliance of the quality management system.
Ensures the quality and safety of products shipped to market and manages manufacturing and quality control activities at domestic and overseas manufacturing sites as a marketing authorization holder.
Prepares for, conducts, and follows up on inspections by supervisory authorities, JJRC audits, and Franchise audits, taking the lead as necessary.
Matching Summary
Leads the construction, maintenance, and improvement of internal quality system processes, focusing on the proper establishment, operation, and compliance of the quality management system.
Skills & Requirements
Must-have
Quality Management Systems
Compliance Management
Corrective and Preventive Action
Cross-Functional Collaboration
Process Oriented
Risk Assessments
Nice-to-have
Human-Centered Design
Inclusive Leadership
Developing Others
Give Feedback
Goal Attainment
Key Requirements
Experience in Quality Assurance or Quality Control in medical device/pharmaceutical industry
Knowledge of Japanese regulations (Medical Device Act, GQP, QMS, GMP)
Intermediate PC skills (Word, Excel, PowerPoint)
University degree or equivalent in a science/engineering field
English proficiency (TOEIC 600 equivalent)
Business level English (speaking, reading, writing)