Valera Makarenko
About Valera Makarenko
Valera Makarenko is a Quality Engineer with extensive experience in the field of Electrical and Electronics Engineering. He has worked for various organizations, including the Israel Defence Forces and Biosense Webster, where he currently oversees quality activities and risk management processes.
Work at BioSense Webster
Valera Makarenko has been employed as a Quality Engineer at BioSense Webster since 2018. In this role, he oversees the review of Defect Meetings and Clinical Readiness Results, ensuring that potential regulatory affairs or safety issues are escalated appropriately. He manages design controls and quality activities during the transition from Research and Development (R&D) to production. His responsibilities also include leading design changes and assessments for new product introductions, as well as reviewing and approving Electrical Drawings and Proof of Design Protocols and Reports.
Previous Experience in Quality Engineering
Prior to his current position, Valera Makarenko worked at Shekel Scales Ltd. as a Quality Engineer from 2014 to 2015. He also served in the Israel Defence Forces (IDF) as a QA Supplier Inspector and Supervisor from 2009 to 2014. His experience in these roles contributed to his expertise in quality assurance processes and methodologies.
Education and Expertise
Valera Makarenko studied Electrical and Electronics Engineering at ORT Afula Technological College, where he achieved the designation of Practical Engineer from 2007 to 2009. He furthered his education at Ruppin Academic Center, earning a Bachelor of Engineering (BSc) in Electrical and Electronics Engineering from 2018 to 2022. His educational background supports his technical skills and knowledge in quality engineering.
Quality Management Responsibilities
In his role at BioSense Webster, Valera Makarenko leads the implementation of methodologies and initiates improvements in compliance with standards and regulations for Class III Quality Product Development. He is responsible for leading xFMEA and Risk Management processes and activities for Class III devices. Additionally, he maintains the Quality Plan and metrics, presenting product status updates to stakeholders.