- Coordination and management of resources. Responsible for compliance with the QMS according to ISO 9001:2015 and ISO 11352:2014- guarantee the quality of energy efficiency services with the aim of continuous improvement in the management of the environmental, social and governance sustainability impact of the company operating on the energy market.- Continuous improvement of business processesPDCAOSATESG

Technical DirectorCoordination and management of resources with managerial responsibilities on the technical, operational and purchasing management for energy efficiency services with a focus on "Configurazione per Auto-Consumo Energie Rinnovabili (CACER)"

Lead to the certification of medical devices for the European market.Act as the main interface with the certification bodies.Management Representative for the coordination of the Corporate QMS according to ISO 13485: 2016.Collaborate with the Management to coordinate the function managers so that the obligations of the ALS manufacturer of medical devices according to the Directive 93/42 / EEC and regulation 745/2017 / EU are respected.Guarantee the quality of ALS products during production processes and processes, in compliance with the requirements requested by the Customer and the applicable industry standards (ISO 13485, ISO 9001, MD DIRECTIVES, PED DIRECTIVES, other applicable product standards).Ensure quality control activities throughout the production process including suppliers.Ensures the correct management of product non-conformities and corrective actions necessary to improve the quality of manufactured products.

Eensure the quality of products during production and processing, in accordance with the requirements of the Customer and applicable industry standards (ISO 13485, ISO 9001, DIRECTIVES MD, PED DIRECTIVES, other applicable product standards).Verify the materials control activities in acceptance, final control in production, manage the non-conformities of the product required for the qualitative improvement of the manufactured products.

Ensure that the conformity of the devices is adequately controlled in accordance with the quality management system according to which the devices are manufactured prior to the release of a device;Ensure that EU technical documentation and EU declaration of conformity are drawn up andupdated;Ensure that the post-marketing surveillance obligations are met;Ensure that the reporting obligations are met;Ensure, in the case of devices subject to clinical investigation, that the declaration referred to in Section II of Chapter II of Annex VI to Regulation 745/2017 / EU is issued.

Engineering and validation of production processes;Engineering of products;Continuous improvement of production;Design and validation of modifications and / or variants on Product.Provide technical support to other Internal Business (Service - Operations - Quality) functions for design products

Coordination of resources.Skill keywords: Design and Validation, Project Chief, Project Management, Planning and Programming, Activity supervisor, Project Report, Technical supplier relation.Job closed successfully: - Validation and change management of medical devices according to 93/42/CE;- Industrialization and outsourcing production of standard equipments;- Reliability emprovement standard equipment;Cooling system design management (Thermostatic and/or Climatic chamber);FAT/SAT – IQ/OQ testing procedure;Product certification (Directive 93/42, EN 12469, UL/CSA, AS3864);Process system certification (ISO 13485, ISO 9001);Trouble shooting and root causes analysis

N°4 direct workers;Technical improvement, Industrial engineering; production methodologies for the achievement of industrial objectives (lean manufacturing, quality, WIP, 5S, T&M, 5S, value stream map, kanban, takt time, ishigawa diagram)Coordination and/or support to cross-functional activities for “continuous improvement” (Value Analyses, Purchase Marketing, Make or Buy Decision, Waste reduction);Plant Development (design of material flow and layout);Study and coordination of productive investments; “Engineering Change Management” pack of Microsoft Dynamics AX.Tutor for master thesis project (Università di Perugia and International internship program Taiwan-Italy for a engineering student).Working Project managed:- Implementation of 5S project on the ULFreezer line production;- Definition and start up ULFreezer line production on Bejing productive site;- Insourcing production for automatic blood fridge;- Outsourcing of laminar flow cabinet;- Validation and start up production of new medical products according to 93/42/CE.

Direct coordination of “Ultra Low Freezer -40°C e -80°C” and “Environmental standard Climatic Chamber” line production.Layout and plant logistic analysisValue stream map analysisBill of materials and working cycles management in ERP;Project Manager for the PDM implementation (Teamcenter Datacenter Manager)Operating procedure creation;Service training (on site and out site)Responsible for KPI of product family:- On Time delivery- Stock quantity- Lead timeDevelopment and application of lean methodologies to ménage a production flow. Material planners and buyer activities coordination (machining and assembling).Robust Design, FMEA and DMAIC process on freezer design “leading project” (Six Sigma)

Mechanical design of new prototypes, cost analysis, searching new products and issue of documentation for estimates and offering. Prototype production controller and contact with the suppliers.