Vernon Hills, Illinois, United States
As a Medical Device Quality Engineer and Specialist, I’m driven by a commitment to improving healthcare through rigorous attention to quality and regulatory compliance. With experience in quality assurance, risk management, and regulatory frameworks like ISO 13485 and FDA requirements, I work to ensure that medical devices not only meet high industry standards but also contribute to the well-being of patients around the world. Throughout my career, I’ve collaborated with diverse teams—from product development to manufacturing and regulatory affairs—to manage and enhance quality systems. Whether it's conducting root cause analysis, leading corrective actions, or preparing documentation for audits and submissions, I focus on creating practical, scalable solutions that keep projects on track and in compliance. My expertise spans a range of medical device categories, with a focus for Class I and Class II devices, where I’ve developed a keen eye for identifying risks early and addressing them in a proactive way. I’m particularly passionate about balancing safety with innovation, ensuring that every product released is not only compliant but also effective and reliable. Ultimately, my goal is to help drive the development of products that make a difference in people’s lives—through careful attention to detail, continuous improvement, and collaboration with teams and the business.
• Communicated with patients concerning insurance, scheduling, and Home-Exercise Programs. • Provided patient care through the use of therapeutic ultrasound, electrical muscle stimulation and guidance of assigned exercises. • Assisted the Office Coordinator with technical issues and data entry involving NextGen Healthcare Information Systems.