The Microbiology Coordinator will work primarily with Volcano products and processes that require environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices.
This position will provide cleanroom management expertise relative to the environmental control of clean rooms managed by Volcano, assuring they meet established applicable regulatory requirements.
This position will establish and maintain processes, document validation protocols, investigate and drive appropriate corrective / preventive actions relative to non-
conformance issues, on-going trending of environmental and sterilization data.
KNOWLEDGE AND EXPERIENCE :
Ethylene oxide Part 1 : Requirements for development, validation, and routine control of a sterilization process for medical device and Part 2 : Guidance on the application of ISO 11135-1