Device Quality Assurance, Manager/Senior Manager

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.