Japan Country Quality Manager

Background

This is a recruitment for a newly established company scheduled to be launched in November 2025. This newly established company is engaged in the emergency care business and provides medical devices that play an important role in acute care management both inside and outside hospitals. These include cardiopulmonary resuscitation devices such as AEDs and automated external defibrillators, as well as emergency medical equipment for professionals and consumers.

Job Summary

Responsible for all aspects of quality assurance and quality management system (QMS) development, operation, and maintenance for medical devices, in collaboration with global HQ/ legal manufacturer and internal departments, based on medical devices sales, rental, and repair services in accordance with applicable laws, regulations, standards and company requirements.

Your roles and Key Areas of Responsibilities

• Understand requirements by applicable regulations and ISO standards, and plan and promote compliance with the internal QMS.
• Execute projects to ensure compliance with QMS standards by global HQ/legal manufacture.
• Ensure quality objectives, evaluate QMS compliance, and report to management/ stakeholders.
• Ensure document/record controls and training management throughout the QMS.
• Ensure the proper execution of regulatory licenses change management.
• Maintain and manage quality agreements with internal and external parties.
• Respond to internal and external quality audits.
• Engage projects/tasks related to the transition and implementation of the internal quality management system.
• Ensure quality assurance, complaint handling, manage nonconforming products, implement corrective and preventive actions, recalls, reporting defects to MAH (e.g. Philips Japan), and coordinate with them, etc.

Requirements (Mandatory)

• > 5 years of experience in the medical devices industry, of which with a minimum of 3 years within quality field such as QA/QMS.
• Knowledge of the PMD Act, ISO 13485, and other applicable regulatory requirements.
• Experience in establishing and operating quality management systems for medical devices
• Language: Japanese (Native level), English (Business Level)

Requirements (Preferred)

• A thorough understanding of AEDs, defibrillators and other emergency care medical devices
• Experience in obtaining medical devices licenses for a newly established legal entity and maintaining it thereafter.
• Ability to design and manage the optimal organizational structure for the quality department in accordance with business expansion progress.