Neelank Tiwari

Neelank Tiwari is a seasoned professional in the medical device industry, currently serving as a Senior Supplier Quality Engineer at Edwards Lifesciences since November 2024. Neelank leads supplier transitions and process validations for Class III medical device components, utilizing FMEA, CAPA, and risk-based frameworks for qualification and regulatory purposes. Additionally, Neelank is a Fractional Project Manager with KoalaT.ai, assisting MedTech startups and SMBs in developing compliant quality systems. Previous roles include serving as a Fractional Quality Leader at FractionL, an IT Quality Analyst at Abbott, and an Enterprise Audit Readiness Program Manager at Medtronic, where significant improvements in audit preparation processes were achieved. Academic credentials include a Bachelor of Science degree in Bioengineering and Biomedical Engineering from the University of California, Riverside, and a Master of Science in Technology and Innovation Management from Northcentral University.