Spandana Skandan
About Spandana Skandan
Spandana Skandan is a Senior Quality Engineer at ZAP Surgical Systems, Inc., where she has worked since 2022. She has a background in biomedical engineering and extensive experience in quality management systems, regulatory submissions, and technical writing.
Work at ZAP Surgical Systems
Spandana Skandan has been employed at ZAP Surgical Systems, Inc. as a Senior Quality Engineer since 2022. In this role, she is responsible for ensuring compliance with quality standards and regulatory requirements. Prior to her current position, she worked as a Quality Engineer at the same company from 2021 to 2022. Her experience at ZAP Surgical Systems focuses on maintaining quality management systems and supporting product development processes.
Education and Expertise
Spandana Skandan holds a Master's degree in Biomedical Engineering from The University of Texas at Dallas, where she studied from 2019 to 2020. She also earned a Bachelor's degree in Biomedical Engineering/Medical Electronics from B. M. S. College of Engineering, completing her studies from 2014 to 2018. Her educational background provides a strong foundation in biomedical engineering principles, complemented by her expertise in quality management systems and regulatory compliance.
Background in Quality Engineering
Spandana Skandan has extensive experience in quality engineering and regulatory affairs. She previously worked as a Biomedical Engineer (Quality and Regulatory Engineer) at the Texas Biomedical Device Center for two months in 2021. Additionally, she volunteered as a Quality and Regulatory Engineer at the same center from 2019 to 2020. Her experience includes hands-on work with CAPA, complaints management, and validation processes, as well as familiarity with ISO 13485 and 21 CFR 820 standards.
Professional Experience in Academia
In addition to her industry experience, Spandana Skandan has held academic positions at The University of Texas at Dallas. She served as a Graduate Teaching Assistant for 11 months in 2020, where she supported educational activities. She also worked as a Graduate Student Researcher for three months in 2019 and as a Graduate Student Assistant for four months from 2019 to 2020. These roles contributed to her understanding of research methodologies and academic collaboration.
Regulatory and Technical Skills
Spandana Skandan possesses a range of technical skills and regulatory knowledge. She is proficient in various technical tools, including MS Office, LabView, MATLAB, Multisim, Proteus, and Visio. Her experience includes writing Small Business Innovation Research (SBIR) grant proposals and involvement in FDA 510K submission strategy for class II devices and IDE submission for class III devices. She is also familiar with the MAUD database and has expertise in risk management according to ISO 14971 standards.