Marco Ortega

I am a Molding Engineer with over 10 years of experience in the medical device manufacturing industry, specializing in injection molding, equipment implementation, and process optimization. I have led cross-functional and cross-cultural teams to drive the successful implementation of new equipment and processes, supporting high-volume manufacturing under strict regulatory frameworks including FDA 21 CFR Part 820 and ISO 13485. In addition to my technical expertise, I hold a specialization in quality systems, with deep knowledge of GMP, CAPA, non-conformance management, and regulatory compliance. My work consistently supports audit readiness and drives quality excellence throughout the product lifecycle. My core skills include process validation (FAT/IQ/OQ/PQ), DOE, tech transfer, and root cause analysis, with a strong focus on reducing scrap, increasing efficiency, and ensuring compliance in GMP environments. I am passionate about continuous improvement, operational excellence, and the impact of high-quality medical products on people’s lives. I thrive in global, fast-paced environments where innovation, technical precision, and cross-functional collaboration drive meaningful outcomes in healthcare manufacturing.