Executive Director, Quality Systems

Kristen Grumet Email: kgrumet@nsf.org
Phone: + 1 202.828.1580

Kristen Grumet has over 25 years of experience including nine years at FDA as a Field Investigator specializing in the area of medical devices, and 16 years working and consulting for medical device companies in quality systems compliance. At FDA, Ms. Grumet served on the Design Control Inspection Strategy (DCIS) and Pacific Region Design Control Training Cadre teams to develop, implement and train industry on the use of the DCIS questionnaire in FDA medical device inspections. She was a Phase II certified performance auditor and a member of the first FDA cadre of certified medical device investigators. She conducted numerous medical device inspections in Europe with the FDA foreign inspection cadre, and has managed successful third-party certifications for companies under FDA consent decree.