Ireland
Hello, I am Gopinath, a Biomedical engineer with 4 years of experience in a multidisciplinary background in quality assurance, packaging design, process validation, project management, New product Introduction, and product design. I have a Master's in Biomedical Engineering from the University of Galway. I have expertise in all aspects of Quality Assurance and Design Assurance which includes framing SOPs, change control, deviation, FMEA, internal audits, performing in-process quality assurance checks, LIMS, Agile, Test Method Validation, Developing Design Freeze Protocol and MES softwares. Currently dealing with Class II ( Tracheostomy), and III Devices (Pacemakers). Furthermore, I am well-versed and trained in handling and troubleshooting medical devices,managing and leading projects and CAD software. Having experience working in various environments, I am highly flexible, goal-oriented, and trained to work under pressure and complete tasks before the deadline with perfection.
• Developed and corrected QMS documents such as Standard operating procedure, change controls, deviation, FMEA, risk assessment and validation protocols. • Prepared and verified batch reports and APR documents. • Conducted validation for equipment such as MHS, DHS, and Incubators. • Conducted Open door and close door study for cold rooms. • Conducted In process Quality Assurance checks in clean rooms, grade A, B, C and CNC areas. • Inspected more than 1000 batches of vials and ensured the best quality for dispatch. • Conducted audits to ensure the process and quality is maintained in the production and Quality control departments.