Head Of Qa (abbott Diabetes Care)

Abbott

Tokyo, Japan
Base pyy: n/a; bonus/equity: not specified; benefi...
Not specified; likely on-site given the nature of the role and location.
10+ years qa experience in medical device
Native japanese and fluent english communication
Strong knowledge of japan mhlw and pmda regulations
Abbott is seeking a Head of QA for its Diabetes Care division in Tokyo, Japan. The role involves managing quality assurance strategies, ensuring compliance with regulatory standards, and leading QA teams to enhance product quality

Job Summary

  • This role serves as the Quality Management Representative for Japan, responsible for managing Marketing Authorization Holders and ensuring compliance with local legal requirements.
  • The incumbent must establish and drive the Quality Assurance strategy for Japan while aligning with global Abbott Diabetes Care strategies and policies.
  • Abbott offers a career with an international company recognized as a great place to work, providing opportunities for growth, diversity, and family care.

Matching Summary

Match Score: 85

Abbott is seeking a Head of QA for its Diabetes Care division in Tokyo, Japan. The role involves managing quality assurance strategies, ensuring compliance with regulatory standards, and leading QA teams to enhance product quality.

Salary

Base pay: N/A; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 10+ years QA experience in medical device
  • Native Japanese and fluent English communication
  • Strong knowledge of Japan MHLW and PMDA regulations
  • ISO13485:2015 certification and global quality systems
  • Experience leading regulatory inspections and audits

Nice-to-have

  • Pharmacist License preferred
  • Experience in distribution warehouse set-up
  • Cross-functional team leadership experience
  • Program/project management skills
  • Training curriculum development experience

Key Requirements

  • Bachelor's degree in Bioengineering, Engineering, or Business
  • 10-15 years of Quality Assurance experience in medical device industry
  • Management experience leading QA teams
  • Proven ability to lead regulatory inspections (PMDA/MHLW)
  • Strong working knowledge of Japan QMS Ordinance and JIS standards

Work Rights

Not specified

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