Reliability, QC Manager

Rakuten 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 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.
Reliability Engineering activities throughout the product life cycle including verification and validation phase and post-production phase.
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.
Required Documents:
Please submit your resume (履歴書and職務経歴書) in Japanese, as well as your CV in English.
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