Summary
Boris González is a Senior Quality Engineer with 8 years of experience ensuring regulatory-compliant quality in medical devices and pharmaceuticals, currently leading quality initiatives at Medtronic. Bilingual in English and Spanish, he blends hands-on validation and statistical analysis with process-risk management, corrective actions, and preventive quality tools like First Time Quality and gemba walks. He holds an MS in Engineering/Industrial Management (4.0 GPA) and a Mechanical Engineering degree, and is proficient with FactoryWorks, SAP, SolidWorks, Minitab and other industry software. Known for translating complex technical requirements into auditable processes, he also coaches teams and supports internal and external regulatory audits. A former undergraduate researcher and competition award-winner in wind-energy systems, he brings an engineering mindset to optimize manufacturability and patient safety.
8 years of coding experience
4 years of employment as a software developer
Master of Science - MS, Engineering/Industrial Management, 4.00/4.00, Master of Science - MS, Engineering/Industrial Management, 4.00/4.00 at Universidad del Turabo
English, Spanish