Sileap Miller
About Sileap Miller
Sileap Miller serves as the Senior Manager of IT Process and Compliance at Inari Medical, where she has worked since 2020. With extensive experience in quality assurance, regulatory affairs, and IT governance, she has held various roles in notable companies, including Abbott Medical Optics and RxSight, Inc.
Work at Inari Medical
Sileap Miller serves as the Senior Manager of IT Process and Compliance at Inari Medical. In this role, she has been responsible for overseeing software change control and ensuring ongoing segregation of duties. She collaborates with various departments to develop compensating controls for IT processes, enhancing the overall compliance framework within the organization. Additionally, she functions as a Subject Matter Expert (SME) for audit support, leveraging her extensive experience in IT governance and compliance.
Previous Experience in Quality Assurance and Regulatory Affairs
Prior to her current role, Sileap Miller worked at Agendia as a Quality Assurance and Regulatory Affairs Consultant for eight months in 2019. She also held the position of Regulatory Compliance Head at RxSight, Inc. from 2015 to 2019, where she focused on ensuring adherence to regulatory standards. Her earlier experience includes roles at Alcon LenSx, Inc. as a Postmarket Surveillance professional and at Abbott Medical Optics as a Program Engineer, contributing to quality assurance and regulatory compliance in the medical optics sector.
Educational Background in Healthcare Administration
Sileap Miller has a strong educational foundation in Healthcare Administration. She earned a Master of Healthcare Administration (MHA) from California State University, Fresno, where she studied from 2005 to 2007. Additionally, she studied at Texas Woman's University, achieving another MHA from 1997 to 2001. This academic background supports her expertise in quality compliance and regulatory affairs within the healthcare industry.
Expertise in ITGC Controls and Compliance
Sileap Miller possesses a strong background in IT General Controls (ITGC), Sarbanes-Oxley Act (SOX) compliance, and quality compliance. Her expertise extends to business system software validation, including Product Lifecycle Management (PLM), Quality Management Systems (QMS), Enterprise Resource Planning (ERP), and clinical databases. This knowledge positions her as a key player in ensuring that IT processes align with regulatory requirements and organizational standards.
Career Progression and Roles
Sileap Miller's career spans over two decades, beginning as a Scientific Analyst at EFI Global from 2001 to 2005. She then transitioned to a Quality Assurance Specialist II role at Cogenics from 2005 to 2007. Following this, she served as a Program Engineer at Abbott Medical Optics from 2008 to 2011, and later worked at Alcon LenSx, Inc. from 2011 to 2015. Her diverse roles have equipped her with a comprehensive understanding of quality assurance, regulatory compliance, and IT processes in the healthcare sector.