Quality Assurance Engineering Specialist Iii
CurrentOversee ethylene oxide sterilization processes for medical devicesOversee gamma radiation sterilization processes for medical devicesReview sterilization, sterility, bioburden, and endotoxin results to confirm compliance with SOPs, WIs, MQIs and ISO standardsUpdate and revise internal company documents through Engineering Change OrdersOwn and implement Deviation AuthorizationsOwn, investigate, and document non-conformancesPerform validations for sterilization processes and product testingSupport Quality Control with GDP, compliance and testing issuesProvide guidance and solutions on eDHR systemTest and design eDHR workflows for implementation