Reliability, Quality Control Manager

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.