Job description
Overview
A global biotechnology company developing next-generation, device-enabled oncology therapies is expanding its quality organization in Japan. This role supports quality control and reliability engineering activities at a domestic manufacturing and inspection facility, working closely with both local and global stakeholders.
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