Summary
Ritika Kapade is an experienced Quality Assurance leader with eight years in medtech and manufacturing quality, currently managing QA at miraDry in the San Francisco Bay Area. She has deep hands-on expertise in CAPA ownership, MRB leadership, risk management (DFMEA/PFMEA), and regulatory alignment with ISO 13485 and FDA 21 CFR 820. Ritika has driven cross-functional improvements from supplier qualification through NPI, routinely authoring and validating SOPs, ECOs, and validation protocols across Arena, EtQ, SAP and Agile systems. She pairs strong statistical and tooling skills (Minitab, Tableau) with practical shop-floor experience inspecting complex medical components and running audits. Known for translating failure investigations into durable process controls, she also trains operators and builds quality governance forums that shorten CAPA lifecycles. Her background uniquely blends supplier-side audits in global manufacturing with automated testing foundations from early software training, giving her a systems-oriented view of quality.
8 years of coding experience
11 years of employment as a software developer
Savitribai Phule Pune University