Experience

Quanta System Spa

• Italy
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Design Control Engineer

  • Apr 2016 - Present



Skytechnology SRL

• Italy
• IT Services and IT Consulting
• 1 - 100 Employee

• Quality Assurance R&D Engineer

  • Sep 2014 - Oct 2015

  For our customer in Medical Device areaAs Quality Engineer for Design Control in Research and Development department in a Medical Company I have to assure that the projects under my responsibility are executed according to internal procedure and applicable standard/rules (ISO13485, directive 93/42, QSR, GAMP5)

• RAMS Consultant

  • Jul 2014 - Aug 2014

  For our customer in Railway AreaWorking out a Safety Review for a signaling wayside device

• RAM Consultant

  • Mar 2013 - Jun 2014

  For our customers in Railway AreaPerforms reliability analyses for different railway systems . Main tasks:• Definition of disposable functional blocks• Definition of Breakdown structure (mechanical and hardware)• FMEA Analysis• MTBF calculation according to MIL Standard• Execution of Preliminary Hazard Analysis• Execution of Hazard Analysis and Hazard Log• Predisposition of RAMS Analysis Report• Predisposition of Maintenance Manuals

• Senior Quality Consultant

  • Feb 2011 - Feb 2013

  For our customer in Railway Area As Quality Project Responsible at the Milano Metro4 and Metro5 sites.Main tasks:• Preparation of Management Plans (Quality Plan, Quality Software Plan, Configuration Plan) • Drafting of contract procedures • Definition of the internal audit program • Performing internal audits and preparation of Audit Reports • Audits of project documentation and testing • Audits to worksite • Execution of training on internal procedures and on Ansaldo Quality System • KPI management• Support to all business functions with regard to the Quality Requirements Show less



Skytechnology SRL

• Italy
• IT Services and IT Consulting
• 1 - 100 Employee

• Quality & Validation Senior Consultant

  • Aug 2010 - Dec 2010

  For our customer in Avionic Area involved in the preparation of Scampi C to reach the maturity level 3 of the CMMI Standard. Main tasks: • Training on M&A process through the dissemination of relevant procedures • Collecting metrics as defined by corporate procedures (through the direct involvement of the Project Manager and Project Leader) • Configuration and filling of the Measurement Repository • Definition and creation of indicators on the internal tool • Adaptation Process Asset Library (PAL) • PAL Filling Show less



Skytechnology SRL

• Italy
• IT Services and IT Consulting
• 1 - 100 Employee

• Quality Senior Consultant

  • Sep 2009 - Apr 2010

  I worked as internal Quality Responsible managing Quality System at Skytechnology

• Quality & Validation Senior Consultant

  • Mar 2008 - Aug 2009

  For our customer in Medical Device AreaQualification and Validation of a new Hemodialysis Machine. Main tasks:• Validation of User Interface in compliance with Use Cases • System Validation in compliance with Technical Specifications and System Requirements • Labelling Validation (Operator's Manual, Quick Reference Guide, Service Manual, Training Manual) • Preparation of documentation for Design Review



Baxter manufacturing

• Rieti Area, Italy

• Validation Specialist

  • Nov 2004 - Feb 2008

  • Validation of Computerized Systems laboratory and production through the preparation and execution of qualification protocols (IQ, OQ and PQ) according to the Best Practice Reference (GAMP, GxP, PICs) • Adjustment of Computerized Systems to FDA, 21 cfr part 11 (ERES Project Manager - Electronic Records, Electronic Signature) • Responsible for the preparation and documentation management system (Validation Master Plan, Gap Analysis, Coverage Assessment, Risk Assessment Procedures for access, security, backup & restore) • Responsible for the configuration and implementation of management tools (Calibration Manager) Show less



Baxter Laboratories Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• CSV

  • 2004 - 2008



Nokia

• Finland
• Telecommunications
• 700 & Above Employee

• Industrial Assistent

  • Mar 2004 - Nov 2004

  In Manufacturing Site, I had following responsibilities: - Management of test on ADM device - Analysis and summary of all ADM malfunctions In Manufacturing Site, I had following responsibilities: - Management of test on ADM device - Analysis and summary of all ADM malfunctions



Elasis - Alcatel

• Rieti Area, Italy

• Test Engineer

  • Jan 2001 - Feb 2004

  As Test Engineer I worked on: - development of testing boards for manual test bench - writing and management of test procedures - interfacing with the manufacturing site for the transfer of testing procedures As Test Engineer I worked on: - development of testing boards for manual test bench - writing and management of test procedures - interfacing with the manufacturing site for the transfer of testing procedures