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

Johnson & Johnson UK

Chuo-ku, Tokyo, Japan
Quality management system (qms)
Japanese regulations compliance
Internal and external audits
This role ensures compliance with Japanese regulations while adhering to company policies and requirements

Job Summary

  • This role ensures compliance with Japanese regulations while adhering to company policies and requirements.
  • Manage documentation and records within the Quality Management System (QMS) and oversee QMS-related training activities.
  • The Sr. Quality System Specialist is located at the Abiomed Japan Tokyo Office and reports to the Quality System Manager.

Matching Summary

This role ensures compliance with Japanese regulations while adhering to company policies and requirements.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • Japanese regulations compliance
  • Internal and external audits
  • QMS documentation and records
  • Supplier audits

Nice-to-have

  • Cross-functional collaboration
  • Process oriented
  • Risk assessments
  • Developing others
  • Inclusive leadership

Key Requirements

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

Work Rights

Not specified

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