With more than 20 years of experience in areas of Quality Systems, Regulatory Compliance and Engineering in large organizations as well as in a start-up environment. Prior to joining InCube Labs, Ms. Gutierrez was the Sr. Director of QA & RA at Oraya Therapeutics. She has also held leadership positions of increasing responsibilities at Auxogyn Inc., LuMend (a J&J company) and Edwards Lifesciences. She has extensive experience in managing all aspects of the Quality Management Systems, Quality Engineering, Regulatory Compliance and Product Development support under US (FDA) and International (ISO) Regulations.