Head Of Qa (abbott Diabetes Care)

Abbott

Tokyo, Japan
Not specified; not specified; not specified
Not specified (potential for hybrid or onsite based on company culture).
10+ years qa experience in medical device industry
Native japanese with fluent english communication
Strong knowledge of japan mhlw and pmda regulations
Abbott is seeking a Head of Quality Assurance for its Diabetes Care division in Tokyo, Japan. The ideal candidate will possess extensive experience in quality assurance within the medical device sector, specifically in regulatory compliance and audit management

Job Summary

  • This role serves as the Quality Management Representative for Japan, responsible for leading quality controllers and safety controllers under legal requirements.
  • The incumbent must establish and drive the Quality Assurance strategy for Japan while ensuring consistent application of Abbott Diabetes Care policies and procedures.
  • Candidates are expected to build effective relationships with local regulators like PMDA and MHLW to influence regulatory direction and ensure compliance.

Matching Summary

Match Score: 85

Abbott is seeking a Head of Quality Assurance for its Diabetes Care division in Tokyo, Japan. The ideal candidate will possess extensive experience in quality assurance within the medical device sector, specifically in regulatory compliance and audit management.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 10+ years QA experience in medical device industry
  • Native Japanese with fluent English communication
  • Strong knowledge of Japan MHLW and PMDA regulations

Nice-to-have

  • Pharmacist License preferred
  • Experience in distribution warehouse set-up
  • Cross-functional team leadership experience

Key Requirements

  • Bachelor's degree in Bioengineering, Engineering, or Business
  • ISO13485:2015 certification and global quality systems knowledge
  • Proven ability to lead regulatory inspections by PMDA/MHLW

Work Rights

Not specified

Tailored Resume

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