Quality Assurance Specialist

FMC

Buzen, Japan
Gmp and iso13485 quality management
Document control and management system
Supplier quality management
Fresenius Medical Care is a global leader in kidney care committed to improving the lives of patients with chronic kidney disease through innovative products and services

Job Summary

  • Fresenius Medical Care is a global leader in kidney care committed to improving the lives of patients with chronic kidney disease through innovative products and services.
  • The Quality Assurance Specialist role involves managing GMP/ISO13485-based quality systems, supporting regulatory inspections, and overseeing supplier quality programs across multiple manufacturing sites.
  • The company offers a professional journey with opportunities to operate and maintain quality management systems, lead data integrity activities, and collaborate with cross-functional teams to ensure consistent quality operations.

Matching Summary

Fresenius Medical Care is a global leader in kidney care committed to improving the lives of patients with chronic kidney disease through innovative products and services.

Skills & Requirements

Must-have

  • GMP and ISO13485 quality management
  • Document control and management system
  • Supplier quality management
  • Regulatory inspection support
  • Data integrity program leadership
  • Internal audits and CAPA management

Nice-to-have

  • Cross-site collaboration
  • Staff training and education
  • Visual inspection of packaging materials
  • SAP data entry
  • Multilingual communication skills

Key Requirements

  • Native-level Japanese communication
  • Bachelor’s degree
  • Pharmaceutical GMP knowledge
  • Medical device QMS (ISO13485) experience
  • Business-level English communication

Work Rights

Not specified

Tailored Resume

Cover Letter