Understandingof medical device regulations and standards
ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience
Experiencein working in a medical device manufacturing industry
GoodProject Management experience
Experiencein process validation, IQ, OQ, PQ Execution & risk analysis
ProcessSpecification, Writing and executing protocols with packagingexperience(optional)
Experiencein component / equipment qualification
Understandingof statistical analysis and process control
Supporting manufacturing line transfer,commissioning of equipment
Performing process validations
Performing equipment qualification
Costanalysis and cost reduction
Ability to express technically complicatedideas and explain them to others.
Excellent written and verbal communicationskills.
Excellent organizational skills.
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Validation Engineer • Cincinnati, OH
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