A global medical technology company is seeking an Associate Manager, Quality Assurance to lead production quality and compliance at its medical device manufacturing site in Fukushima. This is a key leadership role focused on ensuring product safety, manufacturing excellence, and compliance with global quality standards and Japanese medical device regulations. You will manage and develop a QA team while partnering with global stakeholders to maintain world-class quality systems for life-saving medical devices.
Key Responsibilities
- Review and approve production documentation to ensure products meet safety and regulatory requirements
- Identify and resolve quality issues related to materials or finished products that fall outside standards
- Lead investigations into customer complaints to identify root causes and implement corrective actions
- Manage technical and manufacturing changes to ensure product quality and compliance are maintained
- Oversee product testing activities and collaborate with global teams to ensure alignment with international regulations
Required Skills and Qualifications
Experience:
- 5+ years of experience in a technical role such as quality assurance, quality control, or manufacturing
- 3+ years of experience leading and managing a team
- Strong understanding of international quality standards and Japanese medical device laws
- Ability to relocate to or live near Fukushima
Soft Skills:
- Strong analytical mindset with the ability to solve complex quality issues using data and logical thinking
- Coaching-oriented leadership style that supports team development and growth
- Strong collaboration skills for working across cultures in a fast-paced environment
Language Requirements:
- Japanese: Native-level proficiency
- English: Intermediate to Business-level proficiency (professional speaking and writing required)
Preferred Skills & Qualifications
- Experience with Lean, Six Sigma, or continuous improvement methodologies
- Green Belt certification is a plus
- Experience leading end-to-end projects from planning through execution
About the Company
Our client is a global medical technology company dedicated to improving patient outcomes through advances in medical discovery, diagnostics, and healthcare delivery. They manufacture a wide range of medical devices, laboratory equipment, and healthcare supplies used by institutions and researchers worldwide.
Why You'll Love Working Here
- Lead quality and compliance for life-saving medical devices with real impact on patient safety
- People management role with opportunities to coach and develop a dedicated QA team
- Work in a global environment with exposure to international quality systems and stakeholders
- Strong career progression in a highly regulated and high-value manufacturing setting
- Opportunity to take ownership of quality improvement and compliance leadership at plant level
Don't Miss Out - Apply Now!
