Don Fallon has extensive experience in Quality Assurance and Manufacturing. He worked at Applied Biosystems for 25 years in a variety of roles, including QC Chemist, Final Instrument Test Manager, Manufacturing Engineering Manager, Staff Quality Systems Engineer, Production Manager and Senior QA Manager. His experience there included working on both the instrument side (DNA and Protein analyzers) and the consumables side (reagents and oligonucleotides) of the business. He was one of the key players in achieving ISO 9001 for the large Foster City operation. He also provided direct assistance for successful ISO 9001 implementations to two domestic sites as well as the manufacturing site in Japan. Don later served as Director of Quality for 7 years at Thermo Fisher Scientific. He rebuilt the ISO 9001 quality system and drove the 400-person site to a successful ISO 13485 certification, setting the stage for FDA site registration, and for listing one of their Mass Spectrometer/HPLC systems as Class I Medical Devices. Additionally, Don has served as a consultant at two companies where he helped them strengthen their quality system to pass ISO 13485 audits.
Don earned a Bachelor’s degree in Biology from State University College at Oneonta, NY. He has attained ASQ certifications as Certified Quality Auditor, Certified Quality Engineer, Certified Biomedical Auditor, and Certified Manager of Quality/Organizational Excellence. Further professional development includes training in FDA QSR, Risk Management, and ISO 13485 Lead Auditing