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

Johnson & Johnson Innovative Medicine

Chuo-ku, Tokyo, Japan
Not specified (assumed to be office-based given the nature of the role)
Quality management system oversight
Japanese regulations compliance
Qms documentation and records management
Johnson & Johnson is seeking a Senior Specialist/Associate Manager for Quality Systems in Chuo-ku, Tokyo, Japan, responsible for overseeing the quality management system and ensuring compliance with local regulations and company policies. The ideal candidate should have experience in Quality Assurance within the medical device industry, specifically in auditing and managing quality management systems

Job Summary

  • This role ensures compliance with Japanese regulations while adhering to company policies and requirements for the quality management system.
  • Key responsibilities include managing QMS documentation, leading QMS-related IT systems, and responding to internal and external audits.
  • The position requires a minimum of 3 years of experience in Quality Assurance or Quality System within the medical device industry and strong knowledge of Japanese regulations and ISO13485:2016.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Specialist/Associate Manager for Quality Systems in Chuo-ku, Tokyo, Japan, responsible for overseeing the quality management system and ensuring compliance with local regulations and company policies. The ideal candidate should have experience in Quality Assurance within the medical device industry, specifically in auditing and managing quality management systems.

Skills & Requirements

Must-have

  • Quality Management System oversight
  • Japanese regulations compliance
  • QMS documentation and records management
  • internal and external audits
  • supplier audits

Nice-to-have

  • fundamental analytical skills
  • basic English business communication
  • detail-oriented
  • cross-functional collaboration
  • process oriented

Key Requirements

  • 3+ years Quality Assurance/System experience
  • 2+ years internal auditor experience
  • Japan PMD Act knowledge
  • QMS Ordinance knowledge
  • ISO13485:2016 knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter