ISO 13485 Class 8 Clean room using cGMP In-process collection of Medical device components, for testing and measurement, using qualitative and quantitative testing with measurement tools, determines acceptance or rejection of product working from blueprints, engineering change notices, or established operating procedures. caliper, micrometer, Gage pins, microscope, drop gauges, comparator, OGP Predisys SPC Software, SAP inventory software Cross training as incoming inspector Blueprints, SOP, Customer specifications, NCMR Special test: melt flow testing, spring compression and extension testing Participates in mold qualification/validation process

Cleaning of patient specific dialyzers using sterilization techniques to assure dialyzer maintains state regulated pressure and volume levels using computer software that documented all data from reprocessing process, weekly disinfection of dialysis quality water system per SOP’s, testing water to assure all hazardous chemicals used for disinfection have been removed, stocking of supplies FIFO Safety team co-leader responsible for monthly safety inspections, audits Traveled to failing reuse programs to help bring them back into compliance Prepare 1% peracetic acid and calibrated Rentrons daily Tested air quality monthly for reuse room, water room, and patient areas Preparation and shipping of hazardous waste to outside vendor