Quality Assurance Manager - Top Global Medical Device Company
Commercial QA Manager will lead the QA function in support of all Japan commercial operations. The role has direct management responsibility for 6 staff and plays as Domestic Quality Assurance Manager for Medical Device and IVD under PMD Act.
Specific Responsibilities :
• Manage the roles of Quality Control, Quality Assurance and Safety Control in Japan
• Support to achieve Japan Commercial Operations objectives from Quality Assurance perspective
• Maintain and continually improve the quality processes and procedures in Japan commercial operations
• Meet regulatory requirements and establishes policies and procedures.
• Communicate with overseas design and production facilities about quality and reliability problems which need to be solved. There are frequent interactions with manufacturing and engineering in addition to other relevant functional areas and operating entities.
• Ensure projects are completed on time within budget
• Strengthen the QA organization and develop members’ talents
• Bachelor's degree in Science or equivalent
REQUIRED KNOWLEDGE AND EXPERIENCE:
• Minimum 5 years’ experience in Quality Assurance/Quality Control.
• Minimum 3 years’ experience in people management • Deep knowledge of PMD Act ( including related ministry ordinances ) • Deep knowledge of ISO13485
• Experience and/or knowledge of Medical Device / IVD industry
• Experience and/or knowledge of safety management role
• Native Japanese and Business level English (Frequent communication in English by e-mail, teleconference, etc.)
DESIRABLE KNOWLEDGE AND EXPERIENCE:
• Experience of MAH responsible persons (Sokatsu, Hinseki or Anseki)
• Experience of Medical product design, Service or manufacturing.
• Knowledge of “Risk Management Processes”
• ISO13485 Lead auditor