Ms. Eileen Bailey has served as the Vice President of Quality for Orchestra BioMed since May 2018. Previously, she served in various quality, regulatory and clinical roles for Orchestra BioMed’s Focal Therapies development group and its predecessor, Caliber Therapeutics, beginning in March 2012.
Throughout her career, she has had the opportunity to be involved in all aspects of medical device and combination device product development through commercialization. Because of her diverse technical background and expertise in regulatory quality system documentation, industry standards, and cGMP she was invited to serve on the management review board for medical products at W.L. Gore and Associates, Inc. As a project manager, she has guided cross-functional teams through new product/process development and commercialization of medical devices in the fields of general surgery, bariatrics, and coronary catheters. As a functional manager, she has provided training and leadership in the areas of quality engineering and analytical/lab services. Ms. Bailey holds an MS in Polymer Engineering from the University of Massachusetts and a BS in Materials Engineering from Drexel University and is a certified auditor and quality engineer with a strong statistical background.
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