Poornakalyani Sonaachalam Sankaranarayanan

Results-driven and dedicated Medical Quality Management System (QMS) Associate with almost 3 years of progressive experience in the healthcare industry. Known for my meticulous attention to detail and strong analytical skills, I specialize in ensuring compliance with regulatory standards and optimizing quality processes to drive organizational success. With a proven track record of conducting thorough audits, implementing effective corrective actions, and fostering a culture of continuous improvement, I am committed to enhancing patient safety and operational efficiency within healthcare organizations. I am seeking a challenging opportunity where I can leverage my expertise in QMS administration, regulatory compliance, and cross-functional collaboration to make a meaningful impact.

University Hospital Bristol Weston, NHS- Project Intern                                                                                                                                    Feb 2022- Feb 2023

• Designed and developed a novel device to measure radiopharmaceutical retention in patients undergoing radiotherapy, addressing the challenge of accurately monitoring treatment efficacy and patient safety.
• Conducted rigorous testing procedures to ensure the device met stringent quality standards and regulatory requirements, including ISO 13485 and UK MDR, demonstrating a commitment to product quality and compliance.
• Implemented comprehensive verification plans and test protocols to validate the functionality and performance of the device, ensuring alignment with industry best practices and regulatory standards.
• Utilized advanced analytical techniques and statistical methods to analyze test results, promptly identifying potential issues and implementing corrective actions to enhance product reliability and performance.
• Collaborated closely with cross-functional teams to optimize the design and performance of the device, addressing design flaws and ensuring compliance with regulatory requirements.
• Maintained meticulous documentation of verification activities, test results, and design changes, ensuring comprehensive traceability and accountability throughout the product lifecycle.
• Ensured appropriate qualification of production tooling and supported ongoing internal and external calibration activities, enhancing the accuracy and reliability of manufacturing processes.

  DOECE, Anna University- Quality Control Assistant                                                                                   Dec 2019- April 2021

• Collaborated with Systems and Manufacturing Engineering teams to facilitate the seamless transition of designs into production by developing comprehensive design transfer protocols, ensuring alignment with ISO 13485 and regulatory requirements.
• Led the execution of manufacturing process validation activities, resulting in the successful deployment of validated processes following design transfers and major process changes, thereby enhancing product quality and compliance.
• Spearheaded the creation of manufacturing quality instructions and processes for diverse products and sub-components, contributing to the standardization of manufacturing practices and ensuring adherence to regulatory standards.
• Conducted supplier audits and qualification processes to ensure ongoing conformance to established acceptance criteria for products and services, thereby enhancing supply chain reliability and product quality.
• Participated in product design reviews to ensure compliance with quality standards and component manufacturability, facilitating proactive identification and resolution of design-related issues.
• Played a pivotal role in the development and implementation of training programs aimed at enhancing employee awareness and understanding of quality management principles Konexaa India- Biomedical Intern                                                                                                                                     Aug 2020- Oct 2020
• Analyzed market feedback and user data to inform iterative improvements to device design and functionality, ensuring alignment with quality management system (QMS) standards and regulatory requirements.
• Presented research findings and updates on product enhancements at conferences and industry events, emphasizing the device's compliance with regulatory standards and its potential to enhance patient safety and quality outcomes.
• Addressed the challenge of ensuring product traceability and compliance with regulatory requirements and distributed products from initiation to closure.
• Led the coordination of product recalls, including pulling and summarizing product traceability information from information systems and preparing recall customer communications.
• Collaborated with internal stakeholders to establish and communicate recall strategies, ensuring alignment with regulatory standards and organizational objectives.
• Supported quality processes, including Corrective Action/Preventive Action (CAPA) and non-conformance, to enhance product quality and compliance.
• Prepared and summarized data, metrics, and reports as required by management, demonstrating analytical and problem-solving skills.
• Maintained and adhered to applicable SOPs, ensuring compliance with regulatory requirements and organizational standards.

University of Bristol, Bristol: Master of Science in Biomedical Engineering;                                                                                                                                                                      Sep 2021- Sep 2022

Anna University: Bachelor of Engineering in Biomedical Engineering;                                                                                                                                                                     Aug 2017-Aug 2021