Andrea Bulfon

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Andrea Bulfon

Locality: Venice Area, Italy
Summary: Regulatory Affairs & Quality Manager with following experience: Process mapping and description; Key Process Indicators Management; Electronic Data Management System establishment and management; Internal and external audit management; Preventive and corrective actions management; Quality Assurance management in NPD process; Product certification; Customer Claims review; Measurements instrumentation management; Supplier qualification; Incoming inspection management; Management of internal failure analysis laboratory; Establishment of service policies for different countries; Monitoring of service level; Management of external laboratory for repairing; Management of internal laboratory for repairing; Logistic management of repaired goods; Monitoring for NPD Portfolio; Project Selection;
Past: Quality and Service Manager at Fracarro Radioindustrie Engineering Responsible at Tecnomaster srl Electronic Designer at San Marco Imaging Design of a new seismological acquisition network at Centro di Ricerche Sismologiche Udine see less... 1 more...
Education:  Universit degli Studi di Padova Engineering (1985-1990) 

Industry: Medical Devices
Skills: QMS ACCORDING ISO 9001, ISO 13485; ENVIRONMENT MANAGEMENT SYSTEM ACCODING ISO 14001; SAP (QM, PDM, CS); MICROSOFT OFFICE SUITE; PROJECT MANAGEMENT (PMBOK OF PMI STANDARD); RELIABILITY AND FAILURE ANALYSIS; SOFTWARE RELIABILITY ENGINNERING TECHNIQUES; IPC STANDARD; ENVIRONMENTAL TESTING PROCEDURES (COLD, DRY HEAT, DAMP HEAT, VIBRATION, ...); PROCEDURES FOR PRODUCT CERTIFICATION
Experience: SIFI Diagnostic SpA (Privately Held; Medical Devices industry): Regulatory Affairs & Quality Manager,  (July 2007-Present) QUALITY: Quality Management System Representative; Process mapping and description; Key Process Indicators Management; Management review organization; Electronic Data Management System establishment and management; Internal and external audit managemen...
Interests: ADVANCED KNOWLEDGE OF QUALITY MANAGEMENT SYSTEM ACCORDING ISO 9001, ISO 13485; BASIC KNOWLEDGE OF EVIRONMENT MANAGEMENT SYSTEM ACCODING ISO 14001; ADVANCED KNOWLEDGE OF SAP (QM, PDM, CS); ADVANCED KNOWLEDGE OF MICROSOFT OFFICE SUITE; ADVANCED KNOWLEDGE OF IGRAFX FOR PROCESS MODELING; GOOD KNOWLEDGE OF PROJECT MANAGEMENT (PMBOK OF PMI STANDARD); GOOD KNOWLEDGE OF RELIABILITY AND FAILURE ANALYSIS OF ELECTRONICS TECHNIQUES; GOOD KNOWLEDG OF SOFTWARE RELIABILITY ENGINNERING TECHNIQUES; GOOD KNOWLEDGE OF IPC STANDARD FOR ELECTRONIC ASSEMBLIES INSPECTION AND PCB INSPECTION; ADVANCED KNOWLEDGE OF ENVIRONMENTAL TESTING PROCEDURES (COLD, DRY HEAT, DAMP HEAT, VIBRATION, CHANGE OF TEMPERATURE, SHOCK, BUMP, TRANSPORTATION, FREE FALL , SALT FOG.); ADVANCED KNOWLEDGE OF PROCEDURES FOR PRODUCT CERTIFICATION
Interests: career opportunities, consulting offers, job inquiries, expertise requests, business deals, reference requests, getting back in touch
Groups: ANIE - ENVIRONMENT COMMITTEE, AICQ

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