Quality engineering professional specializing in medical device manufacturing quality systems for surgical robotics. I drive operational excellence through strategic process improvements in sterilization validation, supplier qualification, and contamination control. My core expertise spans sterilization validation (EO), biocompatibility testing, bioburden optimization, and ISO Class 8 cleanroom operations. I bring deep knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR 2017/745 requirements. Technical toolkit: Six Sigma Green Belt | Lean Manufacturing | DMAIC | FMEA/PFMEA | SPC | MSA | Process Validation (IQ/OQ/PQ) | CAPA | Risk Management | SolidWorks CSWA | PTC Creo Open to connecting with quality professionals, regulatory specialists, and those passionate about adv...