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Fadi Halawi
Expert in Medical Device Risk Management & Post Market Surveillance
Professional Background
Fadi Halawi is an accomplished professional with extensive experience in quality engineering, reliability engineering, and risk management within the medical device and healthcare sectors. Currently serving as a Risk Manager at iRhythm Technologies, Inc., he has established a strong reputation for his commitment to excellence and innovative problem-solving capabilities. Fadi has dedicated his career to ensuring that medical devices meet stringent safety and efficacy standards, which plays a critical role in patient care and outcome improvements.
Before taking on his role at iRhythm Technologies, Fadi made significant contributions at top-tier organizations such as Edwards Lifesciences and Medtronic. As a Principal Quality Engineer at Edwards Lifesciences, he was instrumental in spearheading quality assurance procedures and ensuring compliance with complex regulatory frameworks. His keen attention to detail and rigorous approach to quality management has resulted in improved processes that benefit both the company and its customers.
Additionally, Fadi has held multiple engineering and compliance roles, including Staff Quality Engineer and Senior Reliability Engineer, where he focused on enhancing product reliability through detailed analysis and testing. His earlier positions as a QA Supervisor and Clinical Trials Coordinator highlight his well-rounded expertise in both quality assurance and clinical research. Fadi’s career is a testament to his ability to adapt and thrive in various roles while consistently delivering outstanding results.
Education and Achievements
Fadi boasts a solid educational foundation, having earned a Bachelor of Science degree in Biochemistry from the prestigious University of California, Santa Barbara. This academic background has equipped him with a deep understanding of biochemical processes, which is particularly relevant in the medical device industry where science and technology intersect.
In addition to his degree, Fadi pursued specialized training as a Certified Lead Internal Auditor in ISO 13485 at BSI. This rigorous program provided him with an advanced understanding of quality management systems specific to medical devices, further enhancing his capability to ensure compliance with international standards.
Fadi has also honed his analytical skills through his studies in Experimental Sciences at high school, which provided a strong foundation for his future endeavors in both biochemistry and quality engineering. His diverse educational background has enabled him to approach challenges from multiple angles, driving innovative solutions in the healthcare field.
Notable Achievements
Fadi Halawi has built a recognized career notable for his key achievements in quality management and engineering. During his time at Edwards Lifesciences, he played a critical role in several projects that successfully navigated the complexities of FDA approvals, which helped reinforce the company's leading position in the market. His work not only ensured compliance but also improved the safety profiles of their medical devices.
At Medtronic, Fadi was a vital asset to the reliability engineering team, where his insights helped curtail product failures and streamlined the product development lifecycle. The impact of his contributions can still be felt today, as his assessments and recommendations led to the implementation of best practices that continue to enhance operational performance.
Furthermore, as a former Senior Compliance Analyst at Focus Diagnostics, Fadi demonstrated his proficiency in regulatory compliance, conducting thorough evaluations that ensured the company's adherence to critical health regulations. His dedication to excellence and unwavering focus on quality make him a sought-after expert in the field of quality assurance and risk management, characterized by his passion for improving patient outcomes and driving innovation within the healthcare industry.
Fadi’s career is a vibrant example of how technical expertise combined with a commitment to quality can make a significant difference in patients’ lives. His unwavering dedication positions him as a leader in his field, continually pushing the boundaries of what is possible in medical technology.