品質システムマネージャー / Quality System Manager
Core
Lead enterprise eQMS/SaaS system management to ensure consistent, compliant QMS operations across global sites and regions.
Role type
Senior IC Quality System Manager (eQMS/SaaS)
Builds
Stable global communication channels and governance frameworks for eQMS/SaaS operations
Domain
Medical Devices / Quality Management Systems (QMS)
Deliverable
dashboards & analysis
Required skills
Global stakeholder coordination, eQMS/SaaS platform operations, ISO 13485/9001 knowledge, system governance, risk-based decision making, cross-functional leadership
Preferred skills
SaaS configuration and workflow management, AI governance knowledge, vendor management, computerized system validation, database concepts
Technologies
eQMS platforms, SaaS systems, ISO 13485, ISO 9001
Responsibilities
Lead the System Management Team to define priorities and operating cadence; Establish governance for system configuration, access control, change control, and release management; Coordinate global communication with Regional Headquarters and sites; Oversee lifecycle management for SaaS/eQMS capabilities; Ensure system processes support auditable and compliant QMS operations. (via careerplan.io/jobs/89-00D-D8-E68-quality-system-manager-at-dot-compliance)
Seniority
Senior, hands-on IC
