Description
A leading medical device company is in immediate need for a QE/Validation Engineer who is a strong communicator, can work in a fast paced environment and holds a strong understanding of inspection processes.The QE/Validation Engineer will have the following responsibilities:
-Evaluate IQ/OQ/PQ documents from manufacturing processes
-Both build upon and write test method validation protocols to ensure acceptance criteria as well as write reports
-Qualification of processes
-Guarantee compliance to ISO 13485 and 21 CFR 820
-Author test method validation reports and recap results
-Verify if data sets meet criteria
-Work cross functionally with quality teams
-Execute and carry out system evaluation, data analysis and product assessment to ensure completed products meet standards
The QE/Validation Engineer must meet the following requirements:
-B.S. in Engineering
-Background with the medical device industry
-Extensive experience with inspection procedures, Receiving Inspection and test methods
-Ability to develop into leadership role
-Self-sufficient yet team oriented
There is an immediate need for the QE/Validation Engineer therefore interviews will be confirmed within a day of submission. Apply now for competitive pay, excellent benefits and the opportunity to work for the leading medical device in the industry! If you are interested, please contact Mary Daly at .