Renuka Ramachandran has extensive experience in the field of software quality and regulatory compliance. Renuka is currently serving as the Director of Software Quality and Regulatory Compliance at Delfi Diagnostics since 2022. Prior to this, they worked at GRAIL, Inc. as an Associate Director of Software Design Compliance from 2018 to 2021. Renuka also held the position of Staff Quality Engineer at Bigfoot Biomedical in 2017, where they collaborated with various teams to ensure compliance with regulations and industry standards. Renuka previously worked at Illumina as a Staff Design Quality Engineer from 2015 to 2017. Earlier in their career, they served as the Manager of System Software Validation at Quest Diagnostics from 2012 to 2015. Renuka also gained experience at Celera Corporation as a Senior System Validation Engineer from 2007 to 2012, and at Bio-Rad Laboratories as an Instrument System Validation Engineer in 2006. Renuka began their career at Agilent Technologies as an Instrument Software Validation Engineer in 2004. Renuka'sroles have entailed managing teams, providing project information, conducting audits, and identifying opportunities for improvement within design and quality system procedures.
Renuka Ramachandran has a Bachelor's degree in Pharmaceutical Sciences from Sri Ramachandra Medical College and Research Institute. Renuka also studied Bioinformatics at the University of California, Santa Cruz. In terms of additional certifications, they obtained the ISO 13485:2016 Lead Auditor certification from BSI in July 2016. In May 2014, they became a Certified Scrum Master through Scrum Alliance. Renuka also received training in Risk-Based Validation of Medical Devices in July 2011, and received certification in Sequencing Technology from Applied Biosystems in April 2007.
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