An established global medical device manufacturer is seeking a Quality Assurance Specialist to strengthen its complaint handling and quality assurance operations in Japan. This role plays a critical part in ensuring patient safety, regulatory compliance, and product quality, working closely with global manufacturing sites and international stakeholders. You will act as a key liaison between Japan and global headquarters while contributing to continuous quality improvement initiatives.
Key Responsibilities
- Investigate medical device product complaints and collaborate with global manufacturing sites to verify technical findings
- Identify root causes of quality issues and work with overseas teams to implement preventive actions
- Provide expert quality and technical guidance to customers, internal engineers, and cross-functional teams
- Analyze market and complaint data to identify trends and recommend product or process improvements
- Serve as the main point of contact between global headquarters and local teams to ensure clear and effective communication
Required Skills and Qualifications
Experience:
- Minimum 3+ years of experience in quality assurance, with hands-on involvement in product complaint handling
- Experience in medical devices or another highly regulated industry is strongly preferred
- Solid understanding of quality systems and structured problem-solving methodologies
Soft Skills:
- Ability to clearly explain technical information to multicultural and cross-functional stakeholders
- Strong analytical mindset with a logical approach to identifying and resolving quality issues
- Collaborative working style with the ability to partner effectively with engineering, sales, and global teams
Language Requirements:
- Japanese: Native level
- English: Intermediate to Business level (used for global meetings and technical documentation)
Preferred Skills & Qualifications
- Practical experience with medical device regulations and quality management systems
- Strong working knowledge of ISO 13485 standards
About the Company
Our client is a global manufacturer of professional dental products and technologies, supplying advanced tools and solutions used by dentists worldwide. Their portfolio includes X-ray systems, dental instruments, and prosthetic solutions. With a strong international footprint, the company is committed to innovation, quality, and improving patient outcomes across global markets.
Why You'll Love Working Here
- Build a global career by collaborating daily with international teams across Europe and the Americas
- Play a meaningful role in improving patient safety through high-quality medical device standards
- Enjoy excellent work-life balance with flexible working hours and remote work options
- Join a stable, well-established organization with long-term career growth opportunities
Don't Miss Out - Apply Now!
