Director, Quality Systems

Ms. Valero-Hansen is Director of Quality Systems and has served Sedia Biosciences since 2014 with her experience developing and managing Quality System functions. Prior to joining Sedia Biosciences, Ms. Valero–Hansen functioned as the Change Configuration Manager and CAPA Coordinator for RS Medical from 2010 to 2014 where she performed stop gap analysis and overhauled the document and change control systems to bring them into compliance. She assisted in ISO and FDA audits and strove to improve and strengthen the company’s Quality System. Previous to her time with RS Medical, Ms. Valero-Hansen served in various roles with HemCon Medical Technologies from 2004-2010. As Quality System Data Coordinator, she improved and maintained the Quality System by leading the Material Review Board, CAPA, non-conformance and process deviation meetings to track and trend quality system activities. In this role, she helped to implement an FDA recommended risk based approach to non-conformances and CAPA as well as significantly decreased the use of planned deviations. Previous to that, Ms. Valero-Hansen served as an Auditor, in addition to being a Quality Control Technician. In this dual role, she monitored the company’s critical suppliers and internal manufacturing processes for continued compliance and assisted in ISO and FDA audits. Additionally, she served on the quality system compliance committee to rewrite and implement Standard Operating Procedures for compliance to and to achieve ISO 13485 certification. Ms. Valero-Hansen received her B.S. in Molecular and Cellular Biology from California State University, Fresno.

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