[quality] Senior Specialist/associate Manager Quality System [heart Recovery]

J&J FAMILY OF COMPANIES

Tokyo, Japan
Not specified (assumed office-based due to location).
Japanese pmd act knowledge
Qms ordinance compliance
Iso13485:2016 standards
Johnson & Johnson is seeking a Senior Specialist/Associate Manager for their Quality System team in Tokyo, Japan. The role involves overseeing the quality management system, ensuring compliance with local regulations, and managing internal and external audits within the medical device sector

Job Summary

  • The Sr. Quality System Specialist represents the company as the person responsible for overseeing the quality management system in Japan.
  • This role ensures compliance with Japanese regulations while adhering to company policies and requirements for medical device operations.
  • The position involves leading internal and external audits, managing QMS documentation, and communicating business issues to senior management.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Specialist/Associate Manager for their Quality System team in Tokyo, Japan. The role involves overseeing the quality management system, ensuring compliance with local regulations, and managing internal and external audits within the medical device sector.

Skills & Requirements

Must-have

  • Japanese PMD Act knowledge
  • QMS Ordinance compliance
  • ISO13485:2016 standards
  • Internal audit experience
  • Supplier audit management

Nice-to-have

  • Cross-functional collaboration
  • Human-centered design
  • Inclusive leadership
  • Developing others skills
  • Risk assessment expertise

Key Requirements

  • Minimum 3 years QA experience in medical device industry
  • Minimum 2 years internal auditor experience
  • Strong knowledge of Japan PMD Act and ISO13485:2016

Work Rights

Not specified

Tailored Resume

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