Position Summary
This position will directly report to Head of Device Quality Assurance (QA) department and have a responsibility for handling and leading operation for quality management processes for the medical devices. It will provide opportunities to work closely with a multidisciplinary team in the Rakuten Medical group while mainly focusing on quality assurance matters in the Japan market.
Key Roles and Responsibilities
- Write, review, and maintain documentation of processes required for Rakuten Medical’s device quality management system.
- Evaluate and manage suppliers both in Japan and overseas, including collaborating with them to address quality challenges.
- Lead or participate in internal and external audits, including audit preparation, planning and closure, and provide expertise during audits as needed.
- Work closely with a global multidisciplinary team to oversee feedback and complaint handling, nonconformance control, corrective and preventive actions, change control, supplier assessment, among others.
- Maintain working knowledge of current regulations, standards, and guidance related to quality management systems and medical devices.
Desired Education, Skills and Experience
- A minimum of a bachelor’s degree in science, engineering, or a related field.
- At least 3+ years of experience and knowledge of relevant medical device industry. Candidates with more experience will be considered for a senior position.
- Experience in quality assurance operations listed below:
- Quality management system,
- CAPA, nonconformance, feedback and complaint handling,
- External and internal audits, and
- 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 (e.g., ISO 14971) is a plus.
- Excellent verbal and written communication skills and ability to read, write, and speak Japanese.
- Experience in communicating in English with business partners and ability to read, write, and speak in English is strongly preferred.
What We Do
Rakuten Medical, Inc. is a global clinical stage biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its AlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. The company has locations in 5 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit www.rakuten-med.com.
