Fresenius Medical Care is seeking a Quality Assurance Specialist to ensure compliance with GMP and ISO13485 standards at their Buzen, Japan location. The role involves overseeing quality management processes, document control, supplier quality management, and supporting regulatory inspections
Job Summary
At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease.
As a Quality Assurance Specialist, you are responsible for ensuring GMP- and ISO13485-compliant quality management and document control across manufacturing sites.
Fulfill granted authorities as Document Control Responsible, Internal Auditor, and Supplier Auditor, contributing directly to the robustness of the quality system.
Matching Summary
Match Score: 85
Fresenius Medical Care is seeking a Quality Assurance Specialist to ensure compliance with GMP and ISO13485 standards at their Buzen, Japan location. The role involves overseeing quality management processes, document control, supplier quality management, and supporting regulatory inspections.
Skills & Requirements
Must-have
GMP and ISO13485 Quality Management
Document control systems
Change control and deviations
CAPA and internal audits
Data integrity initiatives
Supplier quality management
Nice-to-have
Continuous improvement
Cross-site collaboration
Patient safety focus
Key Requirements
Native Japanese communication
Bachelor's degree
Proficiency in Microsoft Word and Excel
Understanding of pharmaceutical GMP
Experience in quality assurance and document control