Sofia Shapira
About Sofia Shapira
Sofia Shapira is an NPD Quality Engineer at Biosense Webster, where she has worked since 2019. She has extensive experience in quality management and engineering, having previously held positions at Afikim Electric Vehicles and Flex.
Work at BioSense Webster
Sofia Shapira has been employed at BioSense Webster since 2019 as a New Product Development (NPD) Quality Engineer. In this role, she leads the implementation of Installation Qualification (IQ), Performance Qualification (PQ), and Operational Qualification (OQ) approvals for suppliers. Her responsibilities include facilitating risk management activities, such as Process Failure Mode and Effects Analysis (PFMEA), and actively participating in the Design Control process. This involves engaging in design reviews and overseeing design transfers, ensuring that quality standards are met throughout the development of new products.
Previous Experience in Quality Assurance
Before joining BioSense Webster, Sofia Shapira worked as a Quality Assurance Manager at Afikim Electric Vehicles from 2016 to 2019. In this position, she was responsible for overseeing quality assurance processes and ensuring compliance with industry standards. Prior to that, she held multiple roles at Flex, including Engineering Leader from 2008 to 2015 and Supplier Quality Engineer (SQE) from 2015 to 2016. Her experience at Flex spanned various aspects of quality engineering and management, contributing to her expertise in the field.
Education and Expertise
Sofia Shapira earned her Bachelor of Science (BS) degree in Industrial Engineering from SCE - The Sami Shamoon College of Engineering, where she studied from 2002 to 2006. This educational background provided her with a solid foundation in engineering principles and quality management practices. Her expertise encompasses validation and verification processes in projects, as well as conducting quality inspections for finished goods and First Article Inspection (FAI) for new products.
Risk Management and Quality Processes
In her current and previous roles, Sofia Shapira has been actively involved in risk management activities, particularly in the context of quality assurance. She facilitates and maintains risk management processes, such as PFMEA, to identify and mitigate potential risks in product development. Additionally, she performs validation and verification processes to ensure that products meet specified requirements and conducts quality inspections to uphold quality standards in finished goods.