Umesh Chandra Koona

Experience

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  Viziotronic Innovations

  Sept 2022 - Oct 2023

  • Development and implementation of quality processes and procedures for software development, ensuring compliance with applicable regulations and standards such as FDA regulations, ISO 13485, IEC 62304, ISO 14971, and ISO 82304.• Developed and implemented 30 + standard SOPs, streamlining quality processes across the organization.• Led quality assurance efforts for a groundbreaking SaMD project on Detecting kidney abnormalities using artificial intelligence/machine learning.• Ensured the project's compliance with relevant medical device regulations and standards, including FDA's Software as a Medical Device (SaMD) guidance and ISO 13485.• Conducted training sessions on ISO 13485, ISO 82304, and Cybersecurity for 10 employees. Show less

  • Quality Engineer

    Feb 2023 - Oct 2023

  • Quality Engineering Intern

    Sept 2022 - Jan 2023
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  3D Future Technologies

  Oct 2023 - now

  Quality Assurance Executive

  • Led all ISO 13485 activities within the organization, ensuring compliance with quality standards and regulatory requirements. • Conducted thorough risk analysis and implemented mitigation strategies to enhance product quality and safety. • Performed comprehensive gap analysis of ISO 13485 documents and processes, identifying areas for improvement and ensuring alignment with regulatory standards and organizational objectives.• Managed documentation processes, ensuring accuracy and completeness in accordance with ISO standards.• Coordinated CAPA investigations and resolutions, driving continuous improvement initiatives. • Provided guidance and Training on ISO 13485, ISO 14971 requirements, and standard operating procedures to employees of 20 members for 80+ hours and evaluated training effectiveness.• Led change control activities within the organization, overseeing identifying, evaluating, and implementing changes to ensure compliance, and efficiency.• Developed and introduced 20 + SOPs in the organization for effective quality processes.• Member of the Validation Committee and conducted validation and re-validation activities to ensure the processes were as per requirement. Show less