Quality Assurance Specialist

Fresenius Medical Care

Buzen, Japan
Not specified (potentially onsite)
Gmp and iso13485 compliance
Quality management system activities
Data integrity programs
Fresenius Medical Care is seeking a Quality Assurance Specialist for its Buzen, Japan location, focusing on ensuring compliance with GMP and ISO13485 standards in the manufacturing of medical products. The role involves managing quality systems, document control, supplier quality, and supporting regulatory inspections

Job Summary

  • As a Quality Assurance Specialist, you are responsible for ensuring GMP- and ISO13485-compliant quality management and document control across manufacturing sites.
  • The team ensures that products from both Buzen and Inukai meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle.
  • We Care for our patients, each other, and our communities We Connect across teams and borders to deliver excellence together We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation.

Matching Summary

Match Score: 85

Fresenius Medical Care is seeking a Quality Assurance Specialist for its Buzen, Japan location, focusing on ensuring compliance with GMP and ISO13485 standards in the manufacturing of medical products. The role involves managing quality systems, document control, supplier quality, and supporting regulatory inspections.

Skills & Requirements

Must-have

  • GMP and ISO13485 compliance
  • Quality Management System activities
  • Data Integrity programs
  • Supplier Quality Management
  • Document management system (QDOK)
  • Batch record and quality record management

Nice-to-have

  • Cross-site collaboration
  • Continuous improvement focus
  • Patient safety advocacy

Key Requirements

  • Native Japanese communication
  • Bachelor's degree
  • Proficiency in Microsoft Word and Excel
  • Understanding of pharmaceutical GMP
  • Understanding of medical device QMS (ISO13485)
  • Practical QA/document control experience
  • Business-basic English communication

Work Rights

Not specified

Tailored Resume

Cover Letter