J Rodrigo Silva Tirado

Lead Quality Assurance Operations for Liquid Oxygen tanks and oxygen concentrator manufacturing, overseeing quality engineering, incoming inspection, calibration, X-ray, PPAP, team development, and quality KPIs. Own NCR/MRB, CAPA, supplier quality, complaint trending, validation, change control, and risk governance; lead audit readiness and QMS execution to FDA QMSR, ISO 13485, MDSAP, and EU MDR r

Technical lead for quality Engineer for Liquid Oxigen systems, providing quality leadership for cryogenic pressure-vessel manufacturing, reliability investigations, supplier issues, process changes, and validation. Led LOX capability and corrective-action work, including a neck-tube improvement that increased Cpk from approximately 0.5 to 1.3 and yield from approximately 53% to 98%; strengthened P

Designed and executed a fractional factorial DOE on critical-to-quality LOX variables; identified two key drivers and reduced output variability by 18%. Led NCR/MRB investigations, containment, root-cause analysis, CAPA, and COPQ trending for LOX and oxygen concentrator manufacturing. Performed an ISO 13485 supplier-program gap analysis and developed and deployed PPAP, including training materials

Led risk and problem-solving activities for product issues, including FMEA, root cause analysis, and CAPA, ensuring robust corrective actions and documented effectiveness. Owned customer feedback/complaint tracking and documentation in alignment with ISO 13485 QMS expectations, supporting post-market trending and continuous improvement. Collaborated extensively with cross-functional teams (Enginee

Performed quality control activities for preinstallation requirements of 700+ devices, reducing installation time by 30% and significantly contributing to risk mitigation. Executed IQ and OQ validation for 30+ devices, ensuring compliance with the Bolivian national regulation and user safety. Led comprehensive supplier evaluations throughout all project phases, including pre-installation and post-

Ensured technical compliance of Medical Equipment for international projects in Bolivia, Nicaragua, Panamá, and Trinidad and Tobago, adhering to local regulatory standards. Evaluated technical documentation for over 200 medical devices, providing selection recommendations that secured full client approval. Improved the device evaluation process by implementing a lookup method on the database for m

Utilized root cause analysis methodologies to identify and address underlying issues in corrective maintenance processes for medical equipment, resulting in efficient troubleshooting, reduced downtime, and improved overall equipment reliability. Achieved a 75% increase in equipment availability by conducting regular preventive maintenance inspections and addressing any issues proactively. Maintain

Successfully installed, and performed preventive and corrective maintenance on a wide range of medical equipment, including X-ray Machines, C-arms, and ultrasounds, resulting in a 100% customer satisfaction rate. Obtained training and qualification for technical support and sales strategies for Laborie Medical Technologies, where I developed a business strategy that incremented nets sales of Bs. 2

Postgraduate Certification in Finance completed in September 2020.

MBA in Project Management completed in December 2019.

Bachelor of Science in Biomedical Engineering completed in August 2018.

Postgraduate Certificate in Evaluation and Management of Medical Equipment.

Postgraduate Certification in Hospital Management.

GD&T training completed.

Small Hand Tool Use Certification completed.

Leadership training completed.

Sales, Service, and Maintenance for Laborie Certification completed.

GI Sales, Service and Maintenance for MMS certification completed.

Lean Six Sigma Yellow Belt Certification completed.

QMS Specialist NB/ISO 9001:2015 certification completed.

Master of Biomedical Innovation and Development completed in August 2023.