Insulet Hires New QA Executive

Bedford, Mass.-based Insulet Corporation has appointed Tracey H. Wielinski its new vice president of global regulatory/clinical affairs and quality assurance. Wielinski brings two decades of experience in quality assurance, regulatory and clinical affairs across a wide range of products in the healthcare industry, including diabetes devices, in which Insulet specializes.

“Tracey is a highly accomplished quality assurance and regulatory affairs executive and we are very pleased to welcome her to Insulet’s management team,” said Duane DeSisto, president and CEO of Insulet. “Demand for the easy-to-use OmniPod insulin pump continues to grow around the world. Tracey’s successful track record in global quality assurance, as well as her expertise in regulatory and clinical affairs, will be an asset to Insulet as we continue to advance our technology.”

Most recently, Wielinski served as president and CEO of Qualtra Consulting, a medical device consulting firm specializing in regulatory and clinical affairs and quality system management. From 2008 to 2011, she was with ElectroSonics Medical, serving as vice president of clinical and regulatory affairs. Previously, Wielinski was with DX Tech, where she was vice president of quality assurance and regulatory affairs. She played the same role at Rapid Micro Biosystems and served as vice president of corporate quality and compliance and chief compliance officer for Oscient Pharmaceuticals. From 1997 to 2004, she held a variety of progressive quality and regulatory management roles at Abbott Laboratories/Medisense Products, Biomec Inc., and Steris Corp. Wielinski holds a BA in biology and communications from the University of Toledo (Ohio), and an MS in health product regulation from Regis College in Weston, Mass.

Insulet produces tubeless insulin pump technology.