Develop, deliver, monitor, and continuously improve instructor-led training, coaching, communications, record reviews, audit and inspection readiness, change management, and problem-solving using the CAPA Checklist, risk management, QMS management, complaint handling, correction and removal, design, manufacturing, and service processes. Practical knowledge of medical device regulations, CAPA, and core QMS disciplines, including production and process quality control, design, complaint handling, correction and removal, and post-market surveillance, along with strong statistical, root-cause analysis, effectiveness-check, sampling, simulation-modeling, Excel, analytics, and AI capabilities.