Position Overview
This role is responsible for overseeing quality control and reliability engineering activities for medical devices at a manufacturing and inspection facility in Japan. Reporting to the head of device quality/facility operations, the position plays a key role in ensuring that products meet regulatory, quality, and reliability requirements throughout their lifecycle.
The role offers close collaboration with cross-functional and global teams, with a primary focus on quality control operations, risk management, and reliability engineering for regulated medical devices.
Key Responsibilities
Oversee quality control operations for medical devices at the facility, including inspection, storage, packaging, and labeling
Perform inspection and investigation activities using mechanical and optical measurement equipment, including high-risk devices such as Class IV laser systems
Ensure accurate documentation of QC activities using both paper-based records and electronic systems
Operate and maintain the facility in compliance with the company’s quality management system (QMS)
Evaluate and manage changes related to internal manufacturing processes and domestic/overseas suppliers
Conduct risk management activities and maintain risk management files using post-production data in accordance with ISO 14971
Lead and support reliability engineering activities across the product lifecycle, including verification/validation and post-market phases
Collaborate with global, cross-functional teams on:
Complaint handling
Nonconformance management
Corrective and preventive actions (CAPA)
Change control
Supplier evaluation and oversight
Required Education, Skills, and Experience
Bachelor’s degree or higher in science, engineering, or a related discipline
Minimum 2+ years of experience in the medical device industry (more experienced candidates may be considered for a senior-level role)
Hands-on experience in quality control operations, including:
Basic statistical analysis
Operation and analysis of measurement equipment and systems
Use and maintenance of mechanical and optical inspection tools
Quality management systems
CAPA, nonconformance handling, and complaint investigation
Medical device storage, labeling, and packaging processes
Strong medical device engineering fundamentals, including:
Technical documentation
Product handling and evaluation
Data analysis
Verification and validation
Risk management
Solid understanding of Japanese medical device regulations, including the PMD Act and applicable guidelines
In-depth knowledge of ISO 13485 and MHLW Ministerial Ordinance No. 169
Excellent Japanese verbal and written communication skills
Ability to communicate with internal stakeholders in English and read/understand technical content in English is strongly preferred