Rafael Bonilla

I am a quality systems and compliance professional with over 15 years of experience in medical device, regulated manufacturing, and automotive environments. My background includes ISO 13485, ISO 9001, FDA 21 CFR Part 820/QMSR, CAPA, nonconformance management, audit readiness, supplier quality, document control, and continuous improvement. I have supported successful audits, helped reduce quality system findings, strengthened CAPA/NCR processes, and improved cross-functional quality discipline. I am seeking a remote or hybrid role in Quality Systems, Compliance, CAPA, Audit Readiness, or Quality Program Management where I can help organizations maintain practical, compliant, and effective quality systems.