Ed Siurek

Throughout his 30+-year career, Ed Siurek has led quality and regulatory departments within the pharmaceutical and medical device industries for both US and international products. He has directed quality and productivity improvement on corporate-wide projects in these sectors, spanning 6 continents and 55+ countries.

Ed’s work has included organizational implementation and oversight of quality management systems, with both primary and direct responsibility for Regulatory Authority interactions. As part of Ed’s role, he has successfully worked with FDA to remediate FDA 483s, warning letters, and consent decrees.

Ed has directed new facility startups and product launches both domestically and abroad. He has led programs and projects serving numerous functions, including medical device product development and launch, ISO 9000 and ISO 13485 certification, EU MDR, quality assurance and regulatory affairs management, Lean/Six Sigma implementation, and global project management leadership, among others.