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.

Lead Quality Assurance and Regulatory Affairs as an executive, maintaining QMS compliance (FDA, ISO, Health Canada), oversee CAPA, complaints, audits, 510(k) and licensing submissions, support product lifecycle and cross‑functional commercial teams, and manage global quality/regulatory partnerships.

Conduct and document medical device product complaint investigations per FDA and ISO requirements. Interface with customers and cross-functional teams to determine root cause, drive corrective/preventive actions, maintain complaint files, perform trend analysis, and support audits and regulatory correspondence.