Alice Kustusch

Alice Kustusch has a diverse work experience in the medical industry. Alice is currently working as a Principal Quality Engineer at Cytovale, where they provide support for product development quality engineering. In this role, they review verification and validation documents and offers strategic recommendations for protocols and reports.

Prior to this, Alice worked at EdgeOne Medical, where they held the positions of Senior Quality Engineer and Quality Engineer. Alice was responsible for managing the company's ISO 13485-2016 compliant Quality Management System and supporting internal and external audits.

Alice also gained valuable experience at Baxter International Inc., where they worked as a Senior Engineer and Engineer II. In their role as a Senior Engineer, they led the transfer of product design history files and updated Luer designs to comply with ISO standards. As an Engineer II, they managed projects involving design history file management and change control ownership for legacy products.

Before joining the private sector, Alice worked as a Research Technician at the University of Arkansas for Medical Sciences and as a Student Researcher at Vanderbilt University Medical Center and UAMS Center for Orthopedic Research.

Overall, Alice Kustusch has a strong background in quality engineering and medical device manufacturing, with experience in product development, compliance, and research.

Alice Kustusch earned a Bachelor of Engineering degree in Biomedical Engineering from Vanderbilt University, completing their studies from 2007 to 2011. In October 2020, they obtained the Certified Quality Engineer (CQE) certification from ASQ - World Headquarters.