Over 15 years of experience in the Medical Device Industry with strong knowledge in Quality Systems (ISO13485:2016 /FDA 21QSR Part 820), including Good Manufacturing Practices and Good Documentation Practices.

Lead Auditor for ISO 13485:2016, BSI Certificate number 8910164-188420

Certified Quality Engineer, American Society for Quality, Certificate Number: 64216.

• Experience in sterilization process (E-beam and Gamma) of medical devices, per ISO 11137-2, ISO 11737-1 and ISO 11737-2.
• Manufacturing processes of Medical Devices such as Infusion Sets, Disposable Bags, Scalpels, Splittable Sheath Introducers, Dilators, Safety Huber Needles, Surgery Kits, Syringes, Blood Pressure Cuff, Burn Bandages, among others.
• Experience in validation of assembly methods such as UV adhesive bonding & curing, solvent bonding, tube cutting, plastic welding (Radiofrequency and Ultrasonic weld), Hot Stamping, Pad Printing, Sewing, bag sealing, pouch sealing, among others.
• Knowledge in risk management (DFMEA, PFMEA, Risk Assessment, Quality Risk Management Tables, Process Hazard Analysis).
• Knowledge in statistical techniques applied for Process Qualification, Process Performance Monitoring, Product Release and Quality System Audits.