Sustaining/Design Quality Engineer
• Provided guidance to the Sustaining Product Development and R&D teams in aspects of the QMS related to Design Controls and Risk Management for real time co-registration side-by-side viewing of OCT intravascular imaging and angiography (Simultaneous angio and OCT image acquisition).• Developed mastery of Class II and III products and analyzed complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on EU MDR principles and data analysis via risk-based approach.• Lead Risk Management File remediation and/or creation activities by delivering Hazard Analysis, D/U/P FMEAs, RMP/RMR, and cybersecurity risk analysis for measurement systems for the guidewires, wireless communication devices, and catheters.• Worked within the QMS to support the Design Assurance process to assure the Design History File (DHF) content integrity with the assessment and implementation of design changes to existing medical devices to comply with the FDA regulations, operating procedures, task assignments and other regulatory bodies.• Identified primary root causes and implemented corrective actions and preventive actions (CAPA) with plan design, investigation, development of actions and effectiveness verification of CAPA implementation for quality issues.• Lead to the process improvement by identifying methods to capture the quality metric data.• Supported internal (Abbott Vascular, Abbott Quality and Regulatory) and external audit responses (BSI, EU MDR). • SME for supporting submission of China PRER (Periodic Risk Evaluation Report) for China NMPA.• Monitored product changes and design updates to ensure the accuracy of IFUs to comply with the regulatory requirements of the region. • Assisted in the creation of quality plans, tools, and training materials by representing as a core quality team member. • Good communication and collaboration with the multiple stakeholders and excellent in technical writing.
