Marisel Pedroza Email & Phone Number

Over 32 years of management experience in the application of vanguard sterilization and microbiology technology. Experienced in: Ethylene Oxide (EO), Gamma Radiation, Steam autoclave, Cleaning/Disinfection/Sterilization of reusable products, Biocompatibility program, Environmental controls, Quality System audits, Gel clot, Kinetic, Photometric LAL Endotoxin testing, CAPA, critical systems and laboratory operations. Hands on experienced in cycle development, validation and routine monitoring processes. Recognized as the sterilization expert driving competitive advantage through innovative solutions that create greater value while maintaining full regulatory compliance. Renowned for uncompromised ethics and integrity. Strong educational background combining industrial microbiology, pre-medicine, and biology. Experience/trained in FDA, CGMP, QSR, QSIT, ANSI/AAMI/ISO, ISO, TIR, ST, MDD, DoH, EN, BS. US Pharma, EU Pharma and OSHA regulations. Fluent in English and Spanish. Specialties: MissionAssist your business achieving competitive advantage through the utilization of vanguard Sterilization and Microbiology technology while in compliance with standards and regulations. Core ValuesUncompromisable ethics and integrityAlways honor our commitmentsOperate in compliance with standards and regulations and within the spirit of the lawDrive competitive advantage to our customersDeliver innovative solutions to create greater value to your business

Listed skills include Design Control, Iso 13485, Sop, Medical Devices, and 25 others.