Shavenese Rosado
Senior Staff Global Quality Compliance @Beckman Coulter Diagnostics
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WORK HISTORY
Senior Staff Global Quality Compliance @Beckman Coulter Diagnostics
Miami-Fort Lauderdale, FL, US
In my role at Beckman Coulter, I oversee the global Quality Management System and manage the notified body audit program across numerous sites. I lead audit readiness and execution activities, ensuring compliance with ISO 13485 and FDA QMSR standards. By partnering with various departments, I drive process improvements and enhance compliance across the organization. My work involves designing digital audit solutions using Microsoft Power Platform to streamline processes.
EDUCATION
Kingston University
Masters in Biomedical Sciences, Microbiology and Immunology
Kingston University
Bachelor of Science - BS, Microbiology and Immunology
ABOUT SHAVENESE ROSADO
I am a Senior Staff Global Process Owner at Beckman Coulter with over 12 years of experience driving quality compliance across multi‑region operations. As a QMS Lead Auditor and Quality Systems professional, I ensure our products and processes meet the highest global standards for quality, safety, and effectiveness, thereby strengthening regulatory compliance and customer trust.My core expertise includes:Audit & Certification Readiness: Leading global audit programs and maintaining compliance with ISO13485, ISO 9001, and applicable country regulations.Quality Assurance Leadership: Driving corrective/preventive actions (CAPA), change plans, and continuous improvement initiatives.Stakeholder Engagement: Building strong relationships to align processes with business needs.Data‑Driven Decision Making: Leveraging Microsoft Office and analytics to streamline workflows and deliver actionable insights.With a master’s degree in Biomedical Sciences from Kingston University and a foundation in microbiology and immunology, I combine scientific rigor with operational excellence to improve health outcomes worldwide. Passionate about innovation and governance, I aim to foster a culture of compliance and continuous improvement that accelerates growth and safeguards certifications.
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