Ana Cristina R.

Quality Compliance Expert

Hello! I'm Cristina, a certified Quality Systems Leader with 3+ years of experience in the medical device industry, currently leading the Quality Management System (QMS) implementation and certification efforts for sites in Costa Rica and Mexico. I specialize in building and maintaining quality systems that comply with ISO 9001, ISO 13485, FDA 21 CFR 820, and other international standards. I’ve developed procedures from scratch, led internal audits, and supported external and certification audits. My experience includes working with tools like TrackWise, MasterControl, Windchill, and advanced Excel for data analysis and documentation control. I’ve also led quality teams of up to 10 people and managed cross-functional collaboration to drive compliance, continuous improvement, and audit readiness. Whether you need help designing or optimizing your QMS, preparing for audits, or ensuring document control compliance, I’m here to bring structure, clarity, and results. Let’s work together to make your quality system robust and audit-ready. Why Choose Me? With a passion for quality, and science background and a dedication to excellence, I guarantee top-notch assistance in your projects. My ability to bridge language gaps and deliver exceptional results swiftly sets me apart. Let's collaborate and elevate your projects to new heights!