求人

Senior Quality Manager

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求人公開日:   2026/02/17

職種

医療機器

給与


¥15,000,000 - ¥18,000,000

求人情報

This is a senior leadership role in a global medical device company in Tokyo. You will lead the Quality function and take responsibility for MAH activities in Japan, own the Japan Quality Management System and make sure products are safe, compliant, and well managed across their full life cycle, from launch to post-market and beyond.

 

You will work closely with both local and global teams and act as the main Quality leader for Japan. This role has strong visibility in the business and a real impact on patient safety, product quality, and regulatory compliance. The Senior Quality Manager will also lead and develop the Japan Quality team and drive continuous improvement to make processes simpler and more effective.

 

About the role

  • Lead and own the Quality Management System in Japan across the full product life cycle

  • Take responsibility for MAH compliance, including post-market activities and vigilance

  • Oversee key quality areas such as QMS, complaints, post-market surveillance, and quality assurance

  • Lead audit and inspection activities and make sure findings are closed and improvements stay in place

  • Support business changes such as new product launches, portfolio changes, and business transitions

  • Update and improve the quality system when regulations or standards change

  • Represent Quality in Japan leadership meetings and support important business decisions

  • Lead, coach, and develop the Japan Quality team and build future leaders

 

Preferred profile

  • Strong experience in Quality leadership within medical devices or a regulated healthcare industry

  • Good understanding of Japan regulations, MAH responsibilities, and quality system requirements

  • Experience owning or leading a Quality Management System and working with audits and inspections

  • Experience with post-market activities such as complaints, vigilance, and risk management

  • Ability to work between global standards and local Japan requirements

  • Comfortable working with data, quality metrics, and quality systems tools

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