Kelley Krisch is a skilled Quality professional with over 20 years of experience as a quality engineer. Most recently, she has provided quality support for early-phase drug and combination device companies, including QMS gap analysis, QMS implementation, eQMS validation, and CMC documentation reviews.

She also brings more than a decade of prior experience supporting Class I, II, and III medical devices. She has successfully led projects focused on remediating quality system issues and has a proven track record in Design Quality, Risk Management, Sustaining Engineering, CAPAs, complaint reviews, manufacturing nonconformance reviews, quality investigations, and post-market engineering analysis.

Her strengths include building strong relationships with individuals and cross-functional teams to accomplish project goals. She is dedicated to driving continuous improvement by collaborating with others to enhance products, processes, or services. She holds a B.S. in Chemical Engineering.