Isis Hernandez
Quality Assurance and Regulatory Affairs Manager @Pristine Surgical
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WORK HISTORY
Quality Assurance and Regulatory Affairs Manager @Pristine Surgical
Naples, FL, US
EDUCATION
Florida International University
Bachelor's Degree, Biomedical/Medical Engineering
ABOUT ISIS HERNANDEZ
Experienced biomedical engineer with 8+ years in the medical device industry, specializing in quality assurance and regulatory affairs. I’ve led efforts in QMS implementation, CAPA, complaint handling, and risk management (ISO 14971), and across both startup and commercial environments.At Pristine Surgical, I oversee national field operations for a Innovative FDA-cleared visualization system, working cross-functionally to ensure product deployment, customer satisfaction, and feedback integration for continuous improvement. My work bridges engineering, RA/QA, and commercial teams to support scalable, compliant growth.Past roles include building a local eQMS from scratch, leading post-market surveillance, and supporting 510(k) submissions and validation testing. I’ve also developed sterilization protocols, cleanroom controls, and audit readiness plans aligned with ISO 13485 and FDA 21 CFR 820.Certified in Lean Six Sigma, FDA inspections, and pursuing additional RAPS credentials, I’m passionate about driving innovation through practical, risk-based compliance.Let’s connect if you’re passionate about quality systems, regulatory strategy, and medtech innovation.
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