당뇨사업부 Qa Specialist

Abbott

Seoul, South Korea
Base: not specified; bonus/equity: not specified; ...
Not specified (assumed onsite based on location)
Bachelor's degree in qa role
4-5+ years medical device or pharma experience
Adverse event handling for reporting
Abbott is seeking a QA Specialist for its Diabetes Division in Seoul, South Korea. The role involves supporting quality operations, ensuring compliance with internal and external standards, and managing documentation and training related to quality systems

Job Summary

  • The incumbent will actively support quality operations in Korea to ensure continuous compliance with internal policies and global standards.
  • Key responsibilities include facilitating communication of Adverse Events to the Korean Regulator (MFDS) and supporting KGMP audits.
  • The role requires managing corrective actions, document control, and training administration while maintaining alignment with MFDS expectations.

Matching Summary

Match Score: 85

Abbott is seeking a QA Specialist for its Diabetes Division in Seoul, South Korea. The role involves supporting quality operations, ensuring compliance with internal and external standards, and managing documentation and training related to quality systems.

Salary

Base: Not specified; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Bachelor's degree in QA role
  • 4-5+ years medical device or pharma experience
  • Adverse event handling for reporting
  • CAPA problem-solving and root cause analysis
  • Document control and training management

Nice-to-have

  • Knowledge of ISO 9001 and ISO 13485 standards
  • Experience with change management and risk assessment
  • Training curriculum development skills
  • External supplier quality management experience
  • Internal audit program management knowledge

Key Requirements

  • Bachelor's degree required
  • 4-5+ years QA experience in medical device/pharma
  • Fluency in spoken and written English

Work Rights

Not specified

Tailored Resume

Cover Letter