• Utilizes clinical product knowledge combined with skills in Product Surveillance to handle complaints and assess risk by providing guidance on clinical workflow and how products are used to identify potentially hazardous situations.

• Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures • Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency • Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc. • Ensure process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts• Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program)• Develop risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process

• Provide manufacturing/engineering process support in accordance with documented procedures and practices • Develop, implement, improve and continuously reinforce established Quality Assurance fundamentals utilized in the local business• Key contributor as part of a complaint handling unit, develop and implement methods and procedures for effective trending of complaints • Facilitate complaint investigation • Engage product design owners to determine effective CAPA • Identify complaints that represent further evaluation under 21CFR Part 803

• Trained comprehensively as a clinical/sales associate and member of the Product Surveillance Group (PSG) in the Aortic Business Unit • Possessed a strong working knowledge of 21CFR Part 820 and International Organization for Standardization (ISO) regulations as well as a complete familiarity and understanding of internal standard operating systems and procedures• Communicated directly with the FDA in making and following up on Medical Device Reports (MDRs) in a timely manner • Worked with product teams to support periodic trend analyses, as well as decisions and recommendations associated with corrective and/or preventive action(s), risk analysis/FMEA, revision/initiation of MDR reporting guidelines, and design control activity• Worked as primary contact with European Union to create procedures and reporting guidelines for individual countries. Built a team of six specialists to manage adverse event reporting outside of U.S