With nearly a decade of experience as a Quality Engineer in the medical device industry, I bring a solid foundation in quality management, regulatory compliance, and hands-on product expertise to every project. My background includes implementing and auditing Quality Management Systems, navigating ISO 13485 and FDA 21 CFR 820 standards, and collaborating on design validation and transfer processes, especially in high-stakes environments where safety and precision are paramount.Throughout my career, I’ve had the opportunity to support innovative projects from prototype assembly to design control and DHF management, gaining insights into both technical and procedural aspects. My work has included contributions to groundbreaking devices involving electrical pulse delivery, from hands-on assembly and troubleshooting to technical SME collaboration on software and firmware.