A leading total solutions foreign affiliated medical device equipment and materials manufacturer with No. 1 market share globally with both growing and stables products in the Japanese market.

The Manager, Quality Assurance is responsible to lead the quality assurance function at the high tech manufacturing site in Tokyo.
●Establish, implement maintain and continuously improve the Quality Management System in Tokyo
●Provide support to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance
●Ensure that the quality system meets domestic and international standards and regulations
●Adhere with all stated company polices, rules and procedures relating but not limited to Quality Assurance & Regulatory Compliance
Other duties:
●Manage Internal Audit program on site
●Manage training system
●Product Release
●Manufacturing Software Configuration and Revision Management
●Calibration
●Document Control
●Ensures all required suppliers are on the global approves supplier list
●Non-Conforming Products
●CAPA
●Complaints handling officer for the site:

● 5 years of experience in Quality in a Medical Device Industry
● Working knowledge of applicable domestic & international regulatory requirements
● At least business level ability