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 regions and sites.
Role type
Senior IC Quality System Manager (eQMS/SaaS)
Builds
Global eQMS/SaaS platform operations and governance
Domain
Medical Devices / Quality Management Systems (via careerplan.io/jobs/89-00D-D8-E68-quality-system-manager)
Required skills
Global stakeholder coordination, eQMS/SaaS platform operations, ISO 13485/ISO 9001 knowledge, system governance, risk management, team 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 including user adoption and continuous improvement; Ensure system processes support auditable and compliant QMS operations.
Seniority
Senior, hands-on IC
