Elton Veby

About Elton Veby

Quality and Regulatory Lead in Medical Device ExcellenceAs a Lead Engineer at HCL Technologies with over 6 years of experience in the medical sector, I specialize in maintaining the highest standards of safety and compliance for complex medical devices. My core focus is driving post-market quality and regulatory adherence through rigorous analysis and proactive risk mitigation.My key areas of expertise include:* CAPA & Investigations: Leading the end-to-end Corrective and Preventive Action (CAPA) process. I execute detailed root cause analysis and author comprehensive investigation summaries for device failures and repair events, ensuring systemic issues are permanently resolved.* Risk Management: Proficiently applying ISO 14971 principles to conduct thorough risk reviews and maintain risk management files. I ensure all device repair and maintenance activities comply with product safety requirements.* Quality Management System (QMS): Upholding strict compliance with the ISO 13485 standard across all service and analysis functions, ensuring QMS integrity and global regulatory alignment.* Repair & Part Analysis: Deeply involved in the technical analysis of device repairs and component performance, providing critical data to quality and engineering teams.* Team Leadership & Client Focus: Responsible for case assignment and workload management for the team, ensuring efficient workflow. I prioritize timely response and submission to clients, serving as a critical point of contact for quality deliverables.I am dedicated to continuous improvement and ensuring that every medical device meets safety, reliability, and stringent regulatory requirements.

Experience

1. Lead Engineer

   HCLTech

   Apr 2025 — Present · Madurai, IN

Education

• Karunya Institute of Technology and Sciences

  Biomedical

  2015 — 2019