Mike Passaglia is a seasoned Senior Quality Professional and the Principal Quality Engineer at Passaglia Quality Consulting LLC, where he leverages his extensive expertise to address complex Quality and Regulatory challenges in the medical device industry. With a robust background in product development and project...
Mike Passaglia is a seasoned Senior Quality Professional and the Principal Quality Engineer at Passaglia Quality Consulting LLC, where he leverages his extensive expertise to address complex Quality and Regulatory challenges in the medical device industry. With a robust background in product development and project management, Mike is adept at crafting innovative, streamlined solutions that not only comply with stringent regulatory standards but also enhance overall product quality. His approach is characterized by a holistic perspective that integrates quality assurance into every phase of the product lifecycle, ensuring that safety and efficacy are prioritized from concept through to market release.
At Passaglia Quality Consulting LLC, Mike is currently spearheading several key projects aimed at optimizing quality management systems for emerging medical device companies. His proficiency in auditing and regulatory compliance allows him to identify potential pitfalls early in the development process, thereby mitigating risks and ensuring that clients meet FDA and ISO standards. Additionally, Mike's strong leadership skills enable him to effectively guide cross-functional teams, fostering a culture of continuous improvement and accountability.
Beyond his technical skills, including proficiency in Microsoft Office and AutoCAD, Mike is a dynamic public speaker and educator, frequently sharing insights on best practices in quality management at industry conferences and workshops. His commitment to customer service and research further enhances his ability to deliver tailored solutions that meet the unique needs of each client. In a rapidly evolving industry, Mike Passaglia stands out as a trusted partner dedicated to driving quality excellence and regulatory compliance in the medical device sector.
