Qualifications/Education:
* BSc in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or min 5 years or more experience if no appropriate science degree.
* Demonstrates expert knowledge of ethylene oxide and radiation principles and industry standards and experience in sterilization process controls is a must.
* Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards.
* Demonstrates experience in dealing with regulatory bodies directly related to medical device sterilization compliance.
* Fluent in English, both verbally and in writing (required)
* Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (required)