A leading global medical device company specializing in pain management and chronic care is seeking a QA Assistant Manager to support the RAQA Manager in overseeing Quality Assurance operations in Japan. This role ensures compliance with the Japan PMD Act, QMS Ordinance (MHLW MO No.169), and ISO 13485 while acting as a key liaison with global quality teams.
業務内容:
Implementing and maintaining the QMS per Japanese regulations
Serving as Domestic Quality Assurance Manager when assigned
Overseeing complaint handling and product investigations (e.g., ETQ)
Managing supplier quality and 3PL distribution partners
Leading preparations for PMDA inspections and corporate audits
Tracking CAPA implementation and ensuring timely closure
応募資格:
Minimum 7 years of experience in Quality Assurance in the medical device industry
Strong knowledge of Quality Management Systems (QMS) and regulated environments
Experience supporting audits and regulatory inspections
Experience working with global teams in multinational organizations
Ability to manage multiple quality activities simultaneously
Business level proficiency in spoken and written English