Microbiologist Device Validation
Nicole Williams has over 20 years of management experience in the medical device industry with expertise in regulatory, and quality system compliance, clinical studies, and medical device validation, including sterilization, reprocessing, material compatibility, biocompatibility, product development and usability testing. Nicole commercialization. She also has experience in post-market support such as clinical training, complaint investigations support, technical support, and reporting, CAPAs, post-market monitoring and clinical evaluation reports. customer surveys.
Prior to Matrix, Nicole served as Vice President, Business Development, at Medical Optics, LLC where she was responsible for establishing and implementing its Regulatory and Quality System compliant with FDA 21 CFR and achieving ISO 13485:2016 certification. In addition, Nicole was responsible for Clinical, Technical, and Sales Support. Before joining Medical Optics, Nicole served as Product Manager, Repair and Reprocessing at Richard Wolf Medical Instruments USA. There, she achieved multiple 510(k) clearances for the reprocessing devices and oversaw/participated in the validation activities (e.g., microbial efficacy, material / functional compatibility). Nicole began her medical device career at STERIS Corporation, where she grew to be Supervisor of its Device Testing and Development Program, responsible for the validation activities to demonstrate the microbial efficacy and material compatibility of leading reusable medical devices from companies such as Olympus, Pentax, Richard Wolf, and ATL. She performed and oversaw hundreds of microbial efficacy testing – including both direct device inoculation simulated use testing, AOAC microbial efficacy carrier testing – as well as material and functionality compatibility post-reprocessing, working closely with the device manufacturers.
Nicole Prior to working at Matrix Medical, Ms. Williams held several positions all revolving around Regulatory and New product development. Most recently she served as VP of Business Development, responsible for establishing and maintaining the Regulatory and Quality system and Clinical and Technical Support. During her career, Ms. Williams has submitted several 510K’s and performed many supportive tests and reports required. She has prepared multiple submissions, achieved market approvals and maintained ongoing registration with FDA, EU, Australia, and Canada. Her specialty is Medical Devices and Medical Device Reprocessors. She ran departments fully responsible for the compatibility of medical devices and their clinical use.
Ms. Williams earned a Bachelor of Science degree BS in Microbiology, and with a minor in Chemistry from Gannon University.