As a Manager, Quality Engineering at J&J MedTech, I oversee and support the quality engineering activities for product development, validation, and manufacturing of medical devices. With 10 years of experience in the medical device industry, working with Class II and III products such as Structural Heart Implants, Electrophysiology Catheters, Glucose Monitoring Sensors, Surgical Robotics, Connectors, and Injection Molding Components. I am a Certified Six Sigma Black Belt and a Certified Associate of Engineering Management, with extensive knowledge of Quality Management Systems, Regulatory Standards, and Risk Management. My core competencies include sustaining quality engineering, design quality assurance, quality engineering oversight, and staff development. I have successfully driven multi-million dollar increase in revenue through validations and transfer to low-cost manufacturing sites, while ensuring compliance with FDA and ISO requirements. I have also partnered with R&D, Operations, Regulatory, and Sales teams to deliver high-quality products that meet customer needs and expectations. My mission is to provide quality engineering leadership and excellence in the medical device industry, and to contribute to the innovation and improvement of healthcare solutions.