•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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