9 years of experience in Quality System (ISO 13485:2016) within medical industry. Great capacity for analyzing, CAPA’s, NCMR’s, PFMEAs and customer complaints.

Strengths:

• Internal Audit ISO 13485: 2016 / FDA 21QSR Part 820 certification.
• Certified SOLIDWORKS Associate.
• Experience in Quality Management System Development and Risk Management (PFMEA, Risk Assessment).
• Manufacturing processes of Medical Devices such as pacemakers, defibrillators, pipettes, membranes, insulin cartridges, catheters, dialysis equipment, among others.
• Knowledge of resistance welding processes for aerospace processes and NADCAP regulations.
• Minitab
• Participation in Lean Six Sigma Green Belt course, focused on the application of DMAIC tools and statistical techniques for problem solving.