Founder and principal consultant of this consultancy specializing in project roles for medical device manufacturer and pharmaceutical companies in the following areas: • FDA compliant Non-Conformance management, Deviations, purchasing controls, global supplier quality & development including quality assurance (extensive experience in managing and executing remediation or work stream activities related to 483 citation, Recall or Consent Decree) • CAPA/SCAR system management • FDA compliant medical device complaint handling business process • Process Improvement (business & technical) • Supply chain improvements (diagnostic, analysis and recommendations) • Biosensor (strip) technology resolution, development & transfer • Manufacturing technology development & transfer • Due-diligence (product, process & supply chain) For more details, please visit ravibhullar.com * Technology Development & Transfer -Special expertise in disposable biosensor-glucose strips (optical and electrochemical) product design and manufacturing technologies. * Medical device complaint Management Process per FDA requirements, ( per QSR 21 CFT 820.198) * Continuous Process Improvement & Lean Initiative Implementation (Cost Reduction, Efficiency Improvement, Accuracy Improvements, Eliminating Non-Value-Add Activities, Automation and Compliance Management)