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Erin Keith (she/her/hers)

Materials Engineer, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Erin Keith is a materials engineer with the Compliance and Quality Staff (CQS) at the Center for Devices and Radiological Health. Collectively CQS is responsible for strategic compliance and quality program development; compliance and enforcement strategy; OPEQ compliance and quality review policies and practices; as well as CDRH and ORA joint policy development. She is currently focused on the quality program development, and activities related to implementing the new Quality Management System Regulation (QMSR). Erin also represents FDA on international harmonization and standards development activities focusing on areas related to risk management and advanced manufacturing.
Erin has 20+ years of experience with the Food and Drug Administration. She has previously held numerous management and staff positions throughout CDRH and FDA. These positions have included the Associate Director for Compliance and Quality, Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) in Office of Device Evaluation (ODE); Deputy Director for the Division of Orthopedic Devices in ODE; the Assistant Country Director for Medical Devices in India Office; Master Reviewer Compliance Officer in Office of Compliance; and a premarket reviewer in ODE.
She obtained her BS in Materials Engineering from Rensselaer Polytechnic Institute and her MS in Materials Science and Engineering from Northwestern University.

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