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

Johnson & Johnson MedTech

Chuo, Japan
Not specified (assumed office-based due to location)
Quality management system (qms) documentation
Qms-related it systems implementation
Internal and external quality audits
Johnson & Johnson MedTech is seeking a Senior Specialist/Associate Manager for Quality Systems in Chuo, Japan. This role is responsible for overseeing the quality management system, ensuring compliance with Japanese regulations, and managing quality audits within the medical device industry

Job Summary

  • The Sr. Quality System Specialist represents the company as the person responsible for overseeing the quality management system and ensuring compliance with Japanese regulations while adhering to company policies and requirements.
  • This role manages documentation and records within the Quality Management System, leads QMS-related IT systems, responds to internal and external audits, and oversees QMS-related training activities.
  • The position requires adherence to all applicable laws, regulations, and company guidelines related to Health, Safety and Environmental practices and involves communicating business-related issues or opportunities to the next management level.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Senior Specialist/Associate Manager for Quality Systems in Chuo, Japan. This role is responsible for overseeing the quality management system, ensuring compliance with Japanese regulations, and managing quality audits within the medical device industry.

Skills & Requirements

Must-have

  • Quality Management System (QMS) documentation
  • QMS-related IT systems implementation
  • Internal and external quality audits
  • Compliance with Japanese regulations
  • Quality system training oversight
  • Health, Safety and Environmental practices

Nice-to-have

  • Cross-Functional Collaboration
  • Inclusive Leadership
  • Human-Centered Design
  • Developing Others
  • Goal Attainment
  • Detail-Oriented
  • Give Feedback

Key Requirements

  • Minimum 3 years in Quality Assurance or Quality System
  • Minimum 2 years internal auditor experience
  • Knowledge of Japan PMD Act and QMS Ordinance
  • Familiarity with ISO13485:2016 standards
  • Basic English business communication skills

Work Rights

Not specified

Tailored Resume

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