Position Summary
This position will directly report to Head of Device Quality division/Facility Manager, and have a responsibility for operations for quality controls applied in the medical devices at the facility locating in Chiba prefecture in Japan. It will provide opportunities to work closely with a multidisciplinary team in the Rakuten Medical group while mainly focusing on quality control and reliability engineering activities.
Key Roles and Responsibilities
- Manage quality control activities for Rakuten Medical’s medical devices in the facility including inspection, storage, packaging and labelling.
- Inspection and investigation on medical devices with mainly mechanical and optical measuring equipment including class IV laser devices.
- Documentation of quality control activities in paper based forms and electrical system.
- Operate to maintain the facility in accordance with Rakuten Medical’s quality management system.
- Assessment of changes in Rakuten Medical internal, domestic and foreign manufacturers.
- Risk management for medical devices, and maintenance of risk management files with post-production information per ISO 14971 standard.
- Work closely with a global multidisciplinary team to support complaint handling and nonconformance control, corrective and preventive actions, change control, supplier assessment, among others.
Desired Education, Skills and Experience
- A minimum of a bachelor’s degree in science, engineering, or a related field.
- At least 2+ years of experience and knowledge of relevant medical device industry. Candidates with more experience will be considered for a senior position.
- Experience in quality control operations listed below:
- Basic statistical technique
- Operation and analysis of measuring equipment and system
- Use and maintenance of mechanical and optical equipment
- Quality management system,
- CAPA, nonconformance, and complaint investigation,
- Storage, labelling, and packaging of medical devices.
- Medical device engineering skills (technical documentation, product handling, analysis of data, verification and validation, and risk management)
- Understanding of PMD Act, relevant regulations and guidelines in Japan.
- Thorough knowledge is expected of ISO 13485 and MHLW MO 169.
- Excellent verbal and written communication skills and ability to read, write, and speak Japanese.
- Experience in communicating in English with internal stakeholders and ability to read and understand is strongly preferred.