Fabian Flores Email and Phone Number

• EU MDR Auditor (Europe’s Medical Device Regulation 2017/745).• Manufacturing Post Market Review Owner (Complaints Review Board).• Global Post Market complaints management.• Global Regulatory Reporting.

• Manufacturing Engineering CAPA leader/sponsor (Internal and Supplier CAPA).• Supplier Change Notice (SCN) PM for a customer project.• Manufacturing Reports automation. • Return to Vendor local project lead.• Validations Process sponsorship (Validation strategies design). • Six Sigma Black Belt Certification.

• Manufacturing site Post Market Review owner (Complaints Review Board).• Global regulatory reporting.• Electrophysiology Complaints Transfer Project leader.• OEM’s Complaints management transfer project. • Global Post Market complaints management for EP/Uro/Endo/PI/IC divisions.• New products certification for Post Market analysis (Spencer CIS/Rhytmia/BARD).• Electrophysiology mapping devices Specialist (Trained in California/Boston, USA).

• Quality and Reliability of new product certifications process.• High-Value Inventory owner, primary accountability for internal and external audits/OSHA. • Reliability Stress Lab equipment and process specialization (Trained in Arizona, USA)• Reliability Stress procedure design, technical support, and data extraction. • TPM procedures elaboration (Availability and utilization equipment metrics and indicators).• New products, process and equipment introduction and… Show more • Quality and Reliability of new product certifications process.• High-Value Inventory owner, primary accountability for internal and external audits/OSHA. • Reliability Stress Lab equipment and process specialization (Trained in Arizona, USA)• Reliability Stress procedure design, technical support, and data extraction. • TPM procedures elaboration (Availability and utilization equipment metrics and indicators).• New products, process and equipment introduction and certifications. • BPM Certification. Owner of Procedures of HVI and Reliability flows. Show less

• Preventive/Corrective Maintenance planning for elevators, platforms and automatic stairs.• Electronics, electrical and hydraulics elevator specialist.• Quality audits for equipments and maintenance procedures.