The position works closely with both local teams and overseas manufacturing partners to ensure quality compliance, manage customer complaints, and support broader regulatory and post\-market quality activities.
Key Responsibilities
Maintain and improve the Quality Management System (QMS) in compliance with Japanese regulatory requirements
Manage customer complaints and coordinate investigations with global manufacturing partners
Review, analyze, and evaluate quality information and recommend appropriate actions (CAPA, improvements)
Communicate with regulatory authorities and manufacturing partners regarding quality matters
Support regulatory affairs and post\-market surveillance activities
Collaborate cross\-functionally to resolve quality\-related issues
Required Experience
3+ years of QA experience in the medical device industry in Japan
Experience serving as, or supporting, a Quality Responsible Person (Hinseki) within an MAH structure
Knowledge of the PMD Act and related quality regulations (QMS, GVP, etc.)
Bachelorâs degree in science, engineering, or related field
Native\-level Japanese communication skills; business\-level English preferred
Preferred Experience
Experience with active medical devices
Knowledge of laser devices or regulated electrical equipment
Familiarity with Electrical Safety Law and Radio Act
Work Environment
Tokyo
Flexible work style including remote work and flexible office environment
International team with collaboration across global manufacturing sites
Compensation & Benefits
Competitive salary package (details shared confidentially)
Full\-time position with standard benefits
Why This Role
Exposure to global stakeholders and international manufacturing teams
Work within an open and flexible office culture supporting collaboration and innovation
