NPI Quality Engineer | Starkey Hearing | Eden Prairie, Minnesota, United States
Tushar is a Highly skilled and dedicated NPI Quality Engineer with over three years of experience at Starkey Hearing, driving excellence and efficiency in the global Quality Management System. Tushar is proficient in overseeing the entire product lifecycle, from technical requirements to manufacturing and customer delivery. He has proven expertise in owning and executing multiple CAPAs to reduce Total Returns rate, employing DMAIC and other methodologies. Tushar is considered as an expert at approving R&D designs and spearheading risk management procedures, including Patient Risk Analysis, Design Failure Mode Analysis, Use Failure Mode Analysis, and Process Failure Mode Analysis. Extensive background in conducting research, evaluating devices, and ensuring compliance with FDA regulations at Abbott. Tushar is an accomplished leader with a track record of successfully managing FDA compliance on numerous catheter design projects at Cook Medical and leading 510(K) projects with three successful FDA approvals and he is committed to elevating industry standards through a passion for quality and innovation.
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