Giancarlo Badi Email & Phone Number

2014 – ongoing Validation Manager at Medacta International SA Castel S. Pietro ( CH ), medical device company that develops and produce implant and instrument devices. I’m managing 5 collaborators within the Validation team dedicated to follow all processes validation activities including cleaning and sterilization. Close connection with R&D and Supplier to define validation strategies supporting QA and QC. Results• Issue of all process validation plan ( VMP ) respecting international standards.• Review of Validation procedures and Statistical Methods to support analysis using Minitab.• Issue of IQ-OQ-PQ protocols and report related to processes.• Preparation of Validation budget to reduce validation costs.• Preparation of Validation training for R&D.

Mariano Comense ( Co )

Responsibilities· Quality Manager of the main plant in Mariano Comense and of Branch Offices in Spain , Germany, Usa , India , Turkey and China.· Responsible of HW and SW Quality , Repair Lab and Customer claims.Results / Experiences· Field Failure rate and Internal Failure rate reduction of 60 % .· ATEX product Certification and impact evaluation of ROHS / REACH EU Directive.· Management of 2 collaborators in Italy and frequent contact with Branch Offices.· Issue of Supplier Quality Requirements and Purchasing Procedure. Bonus / Malus Contract agreement with international suppliers. · Management of Customer Satisfaction Questionnaire on web.· Procedures for DSS ( Decision Support System ) and CRM ( Customer Relationship Management )· As Production Manager - Production lay out modified in accordance with " Lean Manufacturing " concept - IPC Production Program modified to the goal of 9 calendar day lead time from date of customer orders.Switching to IS0 9001:2000 / 2008 and CSQ Certification maintained

Responsibility¨ Quality Manager of Cooling Division¨ Responsible of managing Quality issues over the 3 plants – Donora Italy – Candy Domestic Appliance UK and Conta Czech Republic .¨ Responsible of managing product Quality and Customer claims.Experiences¨ ISO 9001 Certification by CSQ obtained in 99 for the Italian plant and in 2000 for UK plant- Start up of New Refrigeration Plant in Czech Republic with introduction of new automatic test based on thermography .¨ ISO 9001 / Vision 2000 Certification to be obtained in Conta by the end of ‘2003.¨ Responsible of 18 collaborators in Italy , 12 in UK and 6 in Czech Republic.

Responsibility¨ Quality Manager of stapler and nails divisions.¨ Responsible of Quality Assurance and introduction of ISO 9001¨ Responsible of Supplier Quality , Incoming inspection and customer claim service.Experiences¨ Introduction of Quality System Procedures with 5 collaborators.¨ Objective and improvement team implementation¨ Support Engineering to solve Quality problems

Civate -- Molteno ( Lc )

Responsibility¨ Supplier Quality Manager and New Product Quality Engineer. ¨ Responsible of Supplier Audits and Vendor Rating ¨ Responsible of Supplier Advanced Quality Plans for New Products Responsible ¨ Responsible of managing Supplier Monthly Report to European Head Quarter Experiences¨ Responsible of Incoming Inspection with 4 collaborators.¨ Strong Supplier Audits experience ( 160 visits ) on different commodities . Suppliers reduction from 350 to 180 maintaining the best ones .¨ Able to produce ISO 9000 procedures to be included in the Quality Manual. - Supplier Quality Manual created.¨ Important experience on Project Control , identification of critical characteristics , FMEA , SPC and Advanced Control Plans. Advanced Quality Planning for New Product created .¨ Used to be Facilitator of Total Quality Sessions and Quality Improvement .¨ Experience on leading New Project Team as Program Manager.

Responsibility¨ Responsible for Incoming and Production Inspections ¨ Hardness / Tensile / Impact / Ultrasonic / Magnaflux and Penetrant Liquid Tests Instruments Calibration Responsible of Statistical Process Control ( SPC ) in production Experiences¨ Skills on raw material and tests. Able to manage Quality Manual Procedures and to deal with the main Auditors like DNV- ISPESL - TUV - LLRR- RINA etc. Experience on Quality Control Plan and X - R Control Chart according to FIAT standard of Automotive ( ISO TS 16949 )

Engineer, Mechanical

Solar Panel Designer