Tammy Huntley serves as a Principal Quality Engineer at Edwards Lifesciences, where she leverages over 25 years of extensive experience in the medical device industry to drive quality assurance and process improvement initiatives, particularly within the Transcatheter Heart Valve (THV) sector. In her current role,...
Tammy Huntley serves as a Principal Quality Engineer at Edwards Lifesciences, where she leverages over 25 years of extensive experience in the medical device industry to drive quality assurance and process improvement initiatives, particularly within the Transcatheter Heart Valve (THV) sector. In her current role, Tammy is a founding member of the Customer Experience Improvement Team, a position she has held since August 2019. This team is pivotal in enhancing customer satisfaction and ensuring that product performance aligns with the highest standards of safety and efficacy.
Tammy's expertise in Corrective and Preventive Action (CAPA) processes is instrumental as she serves as a Subject Matter Expert (SME) for specific THV device complaints. Her responsibilities include providing comprehensive business-level support for THV device refresher training worldwide, ensuring that all stakeholders are well-informed and equipped to address any quality concerns. By collaborating closely with the Global Product Surveillance, Post Market Surveillance, and Global Professional Education teams, Tammy plays a crucial role in fostering a culture of continuous improvement and proactive risk management.
Her cross-functional experience spans Research and Development (R&D), New Product Development (NPD), Manufacturing Operations, and Clinical Affairs, allowing her to approach challenges with a holistic perspective. Tammy's proficiency in tools such as SolidWorks and Pro Engineer, combined with her deep understanding of quality systems and validation processes, positions her as a key contributor to Edwards Lifesciences' mission of advancing patient care through innovative heart valve technologies. Her commitment to excellence and her ability to navigate complex regulatory landscapes make her an invaluable asset to the organization and the broader medical device community.
