Microbiology Coordinator
hace 9 días

Job Description

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.


  • Requires 2+ years experience in a microbiology function within the bio-medical, medical device, or pharmaceutical industry.
  • Knowledgeable in the following Microbiology tests : LAL, Bioburden, Biologic Indicator (BI), Water sampling, pH testing, Environmental Monitoring
  • Demonstrated experience, proficiency and strong technical expertise regarding microbial identification, sterility assurance, contamination control and clean room testing procedures, technique and methods.
  • Knowledgeable of FDA regulations, Quality System Regulations (QSR), ISO 13485, Good Laboratory Practices (GLP) and Japan regulations.
  • Knowledgeable of ANSI / AAMI / ISO 11135-1 : 2007 Sterilization of health care products
  • 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

  • Knowledgeable of ISO 14644-1 through 14644-9 : Clean rooms and associated controlled environments
  • Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", usted acepta que neuvoo recolecta y procesa su dirección de correo electrónico y las palabras clave utilizadas. Esta información será utilizada para suscribirlo a nuestras alertas de correo, de conformidad con lo establecido en nuestra Política de privacidad . Usted podrá darse de baja o retirar su autorización en cualquier momento con tan solo seguir estos pasos .
    Formulario de postulación