Quality Assurance Expert

This position is responsible for leading quality assurance and post-market quality activities for medical devices in Japan. The role is also expected to flexibly support related regulatory, technical, operational, and business activities as needed.

Core Responsibilities

The role ensures compliance across the product lifecycle, while maintaining product quality, business continuity, supply reliability, and customer satisfaction.

This position is responsible for leading quality assurance and post-market quality activities for medical devices in Japan. The role is also expected to flexibly support related regulatory, technical, operational, and business activities as needed.

The role ensures compliance across the product lifecycle, while maintaining product quality, business continuity, supply reliability, and customer satisfaction.

Statutory Appointments

Domestic Quality Assurance Manager

• Manage and supervise manufacturing control and quality control activities to ensure proper execution.
• Provide instructions for corrective actions in the event of nonconformities or quality
• defects, and require maintenance or improvement of product quality.
• Verify the appropriateness of manufacturing processes, records, and the work environment, and request improvements when necessary.
• Reports significant issues related to manufacturing or quality control to the General Marketing Supervisor and proposes necessary actions.
• Assesses regulatory implications of quality-related changes and supports implementation of appropriate regulatory actions.
• Collaborates with global and local stakeholders to ensure compliance with evolving regulatory requirements.
• Manage the operation of the Quality Management System (QMS) and issue instructions to relevant departments.

If necessary, the Domestic Quality Assurance Manager may also serve as the General Marketing Supervisor and/or Sales Office Manager.

Qualifications, experience, know-how and skills

• At least 3 years of experience in quality assurance
• Possesses sufficient knowledge and experience in pharmaceutical regulations, characteristics of medical devices, the entire MAH business process from raw material procurement to product shipment, manufacturing methods and control, quality control operations, and post-marketing safety management, with the ability to comprehensively understand and appropriately assess these areas