1. Spearheaded quality assurance initiatives for Endosurgical products, conducting comprehensive tensile testing, ductility testing, bending stress analysis, die punching evaluations, and meticulous packaging inspections to maintain stringent quality standards.2. Analyze and investigate product complaints related to medical devices from the field as part of post market surveillance, Investigate CAPA. Demonstrated proficiency in supplier communication for product development and processes within the context of OEM-based projects. 3. Employed testing methodologies to assess the performance, durability, and biocompatibility of skin staplers, mesh, tackers, sutures continuous improvement and product specifications.4. Updating quality control standards, methods and procedures to meet compliance requirements. Monitor Quality testing of finished goods and Raw materials, NC, Deviation.5. Work in interpreting and implementing regulatory standards (ISO 13485) to ensure product compliance and market authorization.6. Proven record in developing and implementing robust QA processes, driving product quality from conception to post-market surveillance.7. Participation in new product development discussions, engaging in meetings with senior management to discuss upcoming projects, and conducting market research to assess the current market value for the specific product.8. Collaborating seamlessly with R&D, manufacturing, and regulatory bodies to align quality and regulatory objectives.9. Collaborated with cross-functional teams to identify and resolve quality issues promptly, employing analytical problem-solving skills and continuous improvement methodologies to drive efficiency and across production and testing operations.10. Played a pivotal role in packaging quality control processes, establishing robust inspection protocols to verify product safety, integrity, and compliance with regulatory requirements, thereby enhancing customer satisfaction and brand reputation.

1. Demonstrated proficiency in supplier communication for product development and processes within the context of OEM-based projects.2. Managed the manufacturing operations of PTCA balloon catheters, overseeing plant operations to ensure efficient production processes and timely delivery of high-quality medical devices to customers.3. Led quality engineering efforts for cardiovascular device production, overseeing operations involving laser cutting machines, polishing machines, shape tooling, and various testing protocols to ensure product excellence.4. Report to senior management on company product technical issues and technical developments within the market.5. Troubleshoot and resolve document discrepancies, providing real-time solutions to enhance project efficiency.6. To verify simulation test, Finished goods and Raw material testing results, and supplier certification. 7. Assist the Marketing team to provide technical details.8. Implemented and maintained a robust Quality Management System in compliance with ISO 13485:2016 standards, driving continuous improvement initiatives to enhance product quality, regulatory compliance, and customer satisfaction. 9. Provide crucial assistance and technical expertise to other company departments. Research to discover, develop, and evaluate new products, to prepare a Device history file (DHF).10. Document data accurately and effectively communicate results with internal and external teams. Represents quality clinical interest in multi-disciplinary teams in product development.11. Collaborated with cross-functional teams to identify and resolve quality issues promptly, employing analytical problem-solving skills and continuous improvement methodologies to drive efficiency and excellence across production and testing operations.12. Led cross-functional teams in new product development projects from concept to commercialization, ensuring alignment with customer needs, regulatory standards, and business goals.