
Results-driven Training and Compliance professional with over eight years in FDA-regulated medical device manufacturing. Expertise in employee training, regulatory compliance, and documentation control. Skilled in coordinating training programs, analyzing compliance data, and enhancing operational processes. Bilingual in English and Spanish, with a commitment to continuous learning in Environmental, Health, and Safety.
• Cornerstone administration .
• Working with Agile.
• Supporting audits.
• Operations, Quality, and supervisors.
• Creating reports in Excel.
• Identifying certification gaps.
• Supporting document control.
• Process improvement initiatives.
• Coordinate training and certification activities for manufacturing personnel in a highly regulated medical device environment.
• Maintain employee qualification records, training matrices, and documentation to support regulatory compliance and operational readiness.
• Monitor certification compliance and identify training gaps to ensure employees meet qualification requirements before performing production activities.
• Administer training records using Cornerstone Learning Management System and maintain documentation within company quality systems.
• Support audit readiness by maintaining accurate training records and ensuring documentation complies with company procedures.
• Deliver instructor led training and evaluate employee competency through practical demonstrations and written assessments.
Executed clerical support functions independently for commercial buildings.