Japan Quality Assurance Lead 品質保証責任者【年収1200万円〜1600万円】

We are seeking an experienced, hands-on Quality Assurance Manager with a strong understanding of how quality principles are applied in the IVD or medical devices industry. The successful candidate will possess comprehensive knowledge of quality assurance and its interplay with regulatory requirements, as well as prior experience in managing and hosting regulatory audits.

This role requires a self-motivated individual to lead and oversee the system that ensures the organization’s Japanese operations comply with both internal and external quality standards. A collaborative mindset is essential, as the position will involve close coordination across departments and geographic regions. Lead the implementation of QMS processes and ensure integration with broader QMS harmonization plans.

Host audits by external regulatory bodies in Japan, such as MHLW, PMDA, or Tokyo Metropolitan Authority, to maintain licenses and product approvals. Fulfill requirements of Japanese regulatory roles related to quality assurance (e.g., Domestic Quality Assurance Manager, General Marketing Compliance Officer). Communicate status and professional opinions regarding the quality management system to senior management.

Support QMS changes required for new product introduction into the Japanese market in line with ISO 13485, Ordinance 169, and other regulatory requirements. Approve and oversee releases and changes to medical device / IVD products available in the Japanese market. Develop new and existing QMS processes to meet evolving business needs.

Support QMS processes relevant to clinical laboratories in line with CAP/CLIA and ISO 15189. Lead audits of suppliers in Japan or the broader Asia-Pacific region as required. Lead development of quality agreements with critical suppliers important to operations in Japan. Lead or support internal audit programs as required.

Lead improvement processes relating to operations in Japan, including non-conforming event management, root cause analysis, corrective/preventive action, and effectiveness checks. Lead activities related to field safety corrective actions/recalls in Japan. Collaborate with project teams to ensure QMS and regulatory compliance.

Support day-to-day administrative requirements of the QMS, including document control and record keeping. Assist in designing training programs for QMS procedure implementation. Train relevant employees in QMS procedures owned by QA. Revise processes in response to audit findings. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Support and comply with organizational Quality Management System policies and procedures.

Requirements

Degree in a relevant scientific discipline or equivalent. Qualified quality systems auditor. 3+ years hands-on experience supporting ISO 13485 / Ordinance 169 QMS development, operation, and maintenance. 3+ years process-based auditing of ISO 13485 / Ordinance 169 QMS. 5+ years hands-on experience in the IVD, medical device, or equivalent industry.

Strong knowledge of ISO 13485 and Ordinance 169. Understanding of Good Vigilance Practice (GVP) and Ordinance 135. Knowledge of Japanese PMD Act, US, and EU quality management system regulations. Understanding of product approval processes (e.g., via PMDA or equivalent). Ability to create simple, clear, and concise procedures.

Ability to train others effectively. Fluent in English and Japanese. Demonstrated ability to perform the essential duties of the position. Right to work in Japan without sponsorship.

Benefits

Report directly to Global manager and working with innovative products Competitive salary package Flexible working arrangement