Title: Manager – Quality Assurance (QA)
Department: Quality Assurance
Location: Tokyo
Overview:
• Improve the quality culture of the whole company, be part of the cross-functional team.
• Comply with law regulations, maintain and improve the quality of products.
• Manage and supervise quality assurance task

Key Responsibilities:
• Develop quality policy for QA team
• Oversee planning and strategy for QA division
• Compliance and implementation of corporate requirements
• Provide training to the quality assurance team, improvement of the team knowledge about QA.
• Create Quality assurance group budget, business goals, performance management
• Cooperation with manufacturing plants to promptly implement complaints from the market, improve quality of defects
• Maintenance of quality record to be supervised by regulatory authorities
• Cooperation with other group in the department, quality control of domestic and overseas manufacturing plants, confirmation of manufacturing control situation
• Evaluation of change management information, progress management of introduction situation to domestic

• Strong communication and leaderships skills, that can build relationship with internal external stakeholders
• Knowledge of quality assurance and work experience (over 5 years)
• Fluent Japanese and Business English level – need to communicate with overseas division
• Understanding Medical Devices and Medical Devices Law
• Experience in auditing work inside or outside the company
• Project management experience preferred but not must