Position Summary
This position will directly report to Associate Director in Device Quality department and have a responsibility for handling and leading operation for quality management processes for the medical devices.
Key Roles and Responsibilities
- Responsible for operations in Device Quality function.
- Responsible for monitoring and escalation potential quality issues and opportunities for improvements.
- Responsible for collaboration with cross functional and organization team to interface processes in Rakuten Medical group.
- Maintain working knowledge of current regulations, standards, and guidance related to quality management systems and medical devices.
Desired Education, Skills and Experience
- Bachelor’s degree
- 3 + years of experience and knowledge of relevant Medical Device industry.
- Experience in quality assurance operations listed below:
- ISO 13485, Quality management system
- CAPA, nonconformance, feedback and complaint handling
- External, internal audit
- Quality control, acceptance, inspection, product release
- Quality engineering, risk management
- Monitoring, analysis of data
- Inspection by regulatory authorities, notified bodies, and/or customers.
- Understanding of PMD Act, relevant regulations and guidelines in Japan
- Thorough knowledge is expected of ISO 13485 and MHLW MO 169
- Knowledge of FDA 21 CFR Part 820 is a plus.
- Understanding and experience with the risk-based approach
- Excellent verbal and written communication skills and ability to read, write, and speak Japanese.
- Ability to read in English, and motivation to challenge and learn writing and communicating in English are strongly preferred.
