Abbott is a global healthcare leader focused on breakthrough science to improve people’s health and offers career development in an international environment
Job Summary
Abbott is a global healthcare leader focused on breakthrough science to improve people’s health and offers career development in an international environment.
The role involves establishing and driving the Quality Assurance strategy for Japan, collaborating with global and local stakeholders to ensure compliance and quality standards.
The position requires managing quality issues, audits, and regulatory inspections while fostering effective partnerships within the business and with local regulators.
Matching Summary
Abbott is a global healthcare leader focused on breakthrough science to improve people’s health and offers career development in an international environment.
Skills & Requirements
Must-have
Quality Management Representative for Japan
Compliance with Japan MHLW and PMDA regulations
Develop and manage CAPA action plans
Lead cross-functional QA teams
Audit response and corrective actions
ISO13485:2015 certification
Fluent Japanese and English communication
Nice-to-have
Pharmacist License
Change management experience
Program/project management skills
Training curriculum development
Experience in matrixed organizations
Microsoft Office proficiency
Key Requirements
10+ years QA experience in medical device industry
Management experience leading QA teams
Strong knowledge of Japan QMS Ordinance (MHLW 169) and PMD Act
Proven ability to lead PMDA/MHLW regulatory inspections
Bachelor's degree in Bioengineering, Engineering or Business