Quality Control Manager
Description
The position offers exposure across the full medical device lifecycle, from inspection and release through post-market quality and risk management.
Key Responsibilities
Oversee quality control operations for medical devices, including inspection, storage, labeling, and packaging
Conduct inspections and investigations using mechanical and optical measurement equipment (including laser-based devices)
Maintain quality records and documentation in both paper-based and electronic systems
Ensure facility operations comply with internal quality management systems and applicable regulations
Support risk management activities and maintain post-production risk files
Participate in reliability engineering across validation, production, and post-market phases
Collaborate with global teams on complaints, non conformance, CAPA, change control, and supplier quality
Requirements
Bachelor’s degree in science, engineering, or related field
2+ years of experience in the medical device industry (senior level considered based on experience)
Hands-on experience with quality control operations and measurement equipment
Knowledge of QMS, CAPA, non conformance handling, and complaint investigations
Understanding of medical device regulations in Japan
Working knowledge of ISO 13485 and relevant MHLW ordinances
Native-level Japanese communication skills; English reading and internal communication preferred
Preferred Experience
Experience with reliability engineering or post-market quality activities
Exposure to regulated manufacturing environments with global stakeholders
Familiarity with optical, mechanical, or precision medical devices
Why This Role
Work on highly regulated, clinically impactful medical devices
Collaborate with international, cross-functional teams
Contribute directly to product safety, reliability, and patient outcomes in oncology
Benefits
Location & Employment
Chiba Prefecture (on-site role)
Full-time position