A dynamic Quality and Design Assurance professional whose career has been dedicated to elevating product quality and regulatory compliance within the complex MedTech and Bio-Pharmaceutical sectors. Aniruddha's deep technical background allows him to serve as an authoritative subject matter expert on critical industry standards, including ISO 14971 risk assessment, EU MDR transition, and US FDA regulations.

My experience includes leading cross-functional teams to define, validate, and launch new products, managing the complete Design History File (DHF) lifecycle, and implementing Statistical Process Control (SPC) techniques to reduce manufacturing defects. Proficient in quality methodologies like FMEA, Root Cause Analysis (RCA), and Gage R&R, Aniruddha excels at transforming non-conformance issues into streamlined, compliant processes. Currently serving as a Design Quality Engineer, he brings immediate, real-world insight into process validation (IQ, OQ, PQ) and maintaining a robust quality system.