Sabahuddin Shams

Lead Project Coordinator @NYU Langone Health

Manhattan, NY, US

Lead cross-functional biomedical logistics projects to manage the end-to-end lifecycle of high-risk medical equipment. Oversee compliance, predictive maintenance, vendor performance, and digital integration to enhance operational reliability and meet regulatory standards across hospital operations.• Oversee procurement, calibration, maintenance, and decommissioning of biomedical assets in full alignment with GMP, GLP, ISO 13485, and FDA/TGA quality standards.• Maintain technical documentation and audit-ready validation reports to support internal QMS and external regulatory inspections.• Lead CAPA workflows, deviation tracking, and change control requests in coordination with QA and compliance teams.• Implement SOP-driven procurement strategies and equipment tagging systems (RFID, barcode) to ensure traceability and audit readiness.• Evaluate vendor performance and enforce compliance for third-party service providers handling mission-critical biomedical devices.• Deploy AI/ML models for predictive maintenance planning, reducing downtime and improving life-cycle cost efficiency.• Build KPI dashboards using Power BI to monitor uptime, repair logs, calibration cycles, and SLA adherence.• Integrate equipment and supply chain data with hospital EHR systems using FHIR, HL7, and IHE standards for unified health IT workflows.• Support remote care initiatives by validating medical device readiness for telehealth and remote patient monitoring platforms.• Reduced CAPA closure time by 40% through streamlined process redesign and cross-departmental collaboration.• Contributed to ISO 13485 audit preparation by updating equipment validation files and participating in mock inspections.

University of New Haven

Master's degree, Business Analytics

Bharath Institute of Higher Education and Research

Bachelor of Technology - BTech; Chennai, Biomedical/Medical Engineering