Join a global medical technology company as a Quality Assurance Associate Manager, leading quality operations at the Fukushima site. In this key role, you will manage daily QA activities, support production teams, oversee inspections and quality control processes, and ensure full compliance with internal standards and Japanese regulatory requirements. You will collaborate with teams across Japan, Asia, and global manufacturing partners to maintain high-quality medical device production.
Key Responsibilities
- Lead, manage, and develop the production quality assurance team at the Fukushima facility.
- Provide final approval for all production and quality-related documentation.
- Oversee core quality processes including complaint handling, change control, and product evaluations.
- Manage incoming material inspections and quality checks for finished products.
- Supervise daily operations and testing in the quality control laboratory.
- Ensure full compliance with internal QMS, Japanese regulations, and global standards.
- Collaborate with cross-functional teams in Japan and international regions to resolve quality issues and support continuous improvement.
Required Skills and Qualifications
Experience:
- Bachelor's degree or higher in science or engineering.
- 5+ years of experience in technical fields such as manufacturing, quality assurance, or production engineering.
- Knowledge of ISO standards such as ISO 13485 and ISO 9001.
- Understanding of Japanese regulations including the PMD Act and QMS requirements.
- Basic financial skills for budgeting and resource planning.
Soft Skills:
- 3+ years of people management experience with strong leadership and coaching skills.
- Logical problem-solving ability to address technical issues effectively.
- Strong project management capability and cross-functional communication skills.
Language Requirements:
- Japanese: Native level.
- English: Intermediate to business level for reading, writing, and meetings.
Preferred Skills & Qualifications
About the Company
Our client is a global medical device organization dedicated to ensuring that advanced healthcare technologies meet Japan's safety and regulatory requirements. The company supports medical device approval, compliance, and safe market entry by working directly with regulatory authorities and healthcare partners. Their mission is to ensure high-quality, safe, and reliable medical devices are available to patients and healthcare providers nationwide.
Why You'll Love Working Here
- Lead and develop the entire QA team at a key Fukushima manufacturing site.
- Hold final approval authority for product quality and release processes.
- Work directly with regional and global teams across Asia and beyond.
Don't Miss Out - Apply Now!
