Teams at Nihon Kohden America

Own and maintain the medical device Quality Management System (QMS): manage internal/external audits, CAPA, change/document/records control, metrics and management review. Lead quality systems personnel, provide training and cross-functional support, ensure regulatory compliance (FDA, ISO, Canadian MDR), and drive continuous improvement and inspection readiness.

Provide level-1 technical support for Windows-based medical devices and applications: troubleshoot hardware/software/configuration issues, assist with system configuration and updates, handle customer inquiries about repairs/parts/orders, document resolutions, escalate complex issues to higher-tier support, and follow up on QA and repair-related items.

Provide level-1 technical support for Windows-based medical devices and applications: troubleshoot hardware/software/configuration issues, handle repair/status/part requests, document resolutions, escalate to higher-level support as needed, and follow up on QA, repair costs, and PO requests while adhering to company policies.