Device Quality Assurance, Manager/Sr. Manager

Work Location: Futakotamagawa in Tokyo / Funabashi in ChibaStatus: Full-TimeDepartment: Quality Assurance Department in Device Quality DivisionCompany ProfileRakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical and its affiliates are operating in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.Position SummaryThis 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 post-market quality assurance matters, management of licensees, and product release for clinical trials.Key Roles and ResponsibilitiesLead post-market activities including monitoring complaint trends, maintaining risk management file, performing products and parts inspection, among others.Analyze and interpret data applying statistical methods to identify trends, anomalies, and opportunities for improvement.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.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.Understanding of PMD Act, relevant regulations and guidelines in Japan.Thorough knowledge is expected of ISO 13485.Knowledge of FDA 21 CFR Part 820 is a plus.Experience in quality assurance operations listed below:Quality management system,CAPA, nonconformance, feedback and complaint handling,Product release and recall,External and internal audits, andInspection by regulatory authorities, notified bodies, and/or customers.Comprehensive knowledge and practical experience in medical device risk management (e.g., ISO 14971).Hands-on experience applying statistical tools and techniques to calculate sample sizes, analyze data, identify trends, and support process improvements.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.