Edgar Marques Chicaroni Email & Phone Number

State Of São Paulo, Brazil

São Carlos, São Paulo, Brazil

- Reporting directly to the Executive Director, manages projects and teams to implement Lean Production, Construction, Office and TPM concepts and tools in large industrial, logistics and construction clients.- Development of Lean routines and tools (planning, management and continuous improvement) for analysis, balancing and optimization of resources and flows in operations.- Management of plant design with Lean concepts and tools to improve capacity and operational efficiency.- Training and development of teams, management of indicators and Lean sustainability audits.

São Carlos, São Paulo, Brazil

- Reporting directly to the Project Manager, is part of the project to implement Lean Production, Construction, Office and TPM concepts and tools in civil construction and industrial clients.- Development of Lean tools (planning, management and continuous improvement) in civil construction and industrial operations.- Application of TPM concepts and practices to improve equipment management.- Training and development of teams, management of KPIs and Lean sustainability audits.

São Carlos Area, Brazil

- Reporting to the Quality Supervisor I had as main results the restructuring and improvements in the Supplier Management process, projects leadership for implementation of nonconformity management and processes/products controls in the SAP ERP system, development of KPI/data analysis with direct integration in the Power BI software.- Quality Assurance, processes improvement and KPI/data analysis in production and logistic areas using quality engineering tools, SAP, Power BI and collaborative tools (SharePoint, Google Forms, Planner, among others).- Qualifications of production processes and NPI / Improvement projects.- Evaluation and actions for complaints of products and services.- Homologation and management of direct suppliers and implementation of indirect suppliers’ management.- Quality Engineer Certification CQE-ASQ with project leadership to improve Supplier Management processes.- Internal Auditor ISO 9001, ISO 14001 and ISO 45001.

São Paulo Area, Brazil

- Reporting directly to Quality and Operations LATAM Managers as responsible for the Brazil stage of a short term project in Medical Devices and warehousing / distribution processes, had as main results the implementation of a new product labeling operation in a large Distribution Center.- Development and validation of quality/operations processes and equipment qualification (IQ/OQ/PQ/PV) for products labeling of a large Medical Devices Company due to an improvement project in their corporate processes.- Management of project stages with teamwork along with Supply Chain, Engineering, IT, Operations, Quality and other areas to achieve on time execution.- Direct interface with LATAM and USA teams for integrated activities development and management.- Training operations and quality teams on new developed processes and GMP / GDP requirements.- Supervise and provide quality/operations guidance over labeling processes in conformance with all applicable regulations (ISO13485, RDC16, FDA) and corporate requirements.

São José Dos Campos/Sp - Brazil

- Reporting directly to the QA Leadership, had as main results the best performance during internal and corporative audits, improvement of Band-Aid process qualification (DQIQ/OQ/PQ/PV and CSV), technical leadership of the Shop Floor Inspections Team as a benchmark process and a Green Belt Certification 2015-2016 performed in Tapes plant achieving 50% reduction of the length losses in the tape rolls of the main production line.- Quality assurance/QMS in clean room areas and support processes (Factories of Medical Devices, Combination Products and Personal Care / Cosmetics).- Direct participation as QA Expert in several projects related with processes and products changes / improvements conducting different projects scopes, change processes and validation steps (DQ/IQ/OQ/PQ/PV and CSV) based on international standards (ISO 13485, FDA), local requirements (ANVISA) and J&J Policies with all steps for evaluation, monitoring and validation of control processes and softwares in industrial equipments (Obs.: at J&J each project is performed by the management of a change control involving all responsible areas).- Control of KPIs and Management Review, management of nonconformities and corrective / preventive actions.- Review of production documentation and SOP's, GMP/QMS application, training and people development, validation of Cleaning and Sanitization, coordination of environmental controls and microbiological monitoring in GMP areas.- Control and improvement of processes (Quality Tools, PDCA, A3, 5W2H, CAPA, SPC, DMAIC, TPM, FMEA, Risk Analysis).- Technical Leadership of the QA Shop Floor Inspections Team from Mar/2016 to Mar/2017 (8 employees) to periodic monitoring and improvement of GMP/QMS procedures.- Team member in internal and external audits (ISO 13485, RDC 16, RDC 17, RDC 48, FDA, Corporate).

Matão/Sp - Brazil

- Reporting directly to the Plant Manager, had as main results improvement of OEE (Overall Effectiveness Equipments) in 10%, increase of productivity in 20% and scrap reduction in 40%.- Management of production lines for new metal drums (30 to 55 employees) – team organization, production planning, process studies, results focus oriented, maintenance scheduling, TPM implementation and support in analysis and actions of customer complaints.- Administrative management of teams (frequency control, vacation, training).- People development based on profile and performance evaluation.- Coordination of MPS (Mauser Production System) in the assembly and finishing areas – tools of management, control and process improvement.- Responsible for the Production KPIs at Factory's BSC (OEE, Productivity, Waste).

Sorocaba/Sp - Brazil

Nipro bought Edwards Lifesciences on December/2006 with direct transfer between companies.- Reporting directly to the QA Leadership, had as main results the participation as team member in a big change project to transfer of processes and products sterilization from Sao Paulo to Sorocaba with requalification of all processes and review of the entire QMS structure, restructuring of the Internal Audit Program, implementation of injection and extrusion specifications and CSV process.- Responsible for the implementation of Module of Non Conformities Control Microsiga Protheus 10 and CSV process by developing the procedure and all steps for evaluation, monitoring and validation of control software in industrial process equipment (based on GAMP 5, FDA and ANVISA guidelines).- Team member in the implementation and maintenance of the Lean Thinking Project.- Quality assurance / QMS in the clean room areas, logistics and support processes, review of production documentation and SOP’s, studies and process improvement (Quality Tools, PDCA, A3, SPC, FMEA, Risk Analysis), GMP/QMS for medical devices, training and people development, management of KPIs.- Lead Auditor of the Internal Audit Program working with QMS audits in all business processes and suppliers.- Participation in several external audits with certification ISO 13485, RDC 59, FDA and MDD 93/42/EEC.- Qualifications of production processes (IQ/OQ/PQ and CSV), sterilization (ISO 11135), coordination of cleaning and sanitization validation, environmental controls and microbiological monitoring in GMP areas.- Management of nonconformities system and corrective and preventive actions (CAPA), periodic processes inspections and products controls (metrology, functional and lab testing).- Coordination of development and implementation of injection and extrusion specifications.- Technical Leadership of QA/QMS Process Team from Apr/2008 to Mar/2010 (4 employees).

São Paulo/Sp - Brazil

Company acquired by Nipro Medical Ltda in December/2006.- Reporting directly to the Quality Supervisor participated in the implementation of Process Monitoring and restructuring of CAPA System (corrective and preventive actions).- Responsible for quality assurance and process control (QA/QMS) in the clean room, logistics and support processes for Medical Devices (ISO 13485, ISO 9001, MDD 93/42 and ANVISA).- Review of production documentation and SOPs, studies and process improvement (Quality Tools, PDCA, SPC, FMEA), GMP/QMS application, training and development of sterilization qualifications, responsible for supplier qualifications.- Team member in internal and external audits as internal auditor in 2006 and 2007 with approval and certifications.- Experience in raw materials inspections, physicochemical analysis of reverse osmosis water and gas chromatography, monitoring of environmental controls and microbiological monitoring in GMP areas.- Implementation of KPI’s and initial knowledge of the Lean Thinking.

Osasco/Sp - Brazil

Clients: SPP Agaprint Industrial Comercial Ltda. - Osasco and Pirituba/SP- Reporting directly to the Managing Partner, was team member for the preparing and organizing the Osasco Unit for the ISO 9001:2000 certification.- Responsible for developing process mapping, work instructions and SOPs and all QMS requirements.- Implementation of ISO 9001:2000, development and implementation of KPIs, 5S, 5W2H and PDCA.- Analysis and restructuring of processes and business strategies, training and people development.

Marília/Sp - Brazil

- Reporting directly to Quality and Manufacturing Managers, obtained as main result the approval in internal and external audits of quality.- Manufacturing / Processes Team: HACCP studies, preparation of QMS (Quality Management System), application of GMP for food processes, preparation of work instructions and control charts, assistance in preparing for audits and review of Factory’s Standards.- Quality Assurance Team: review, approval, distribution and maintenance of all the Nestlé Quality System documentation and training at Mycotoxin Laboratory.- Member of the Master Team of Tasting and participation in the Social Project Nutrir.

Specialization - Fundação Vanzolini, Quality And Productivity (Production Engineering)

Activities and Societies: Statistical Tools for Evaluation and Improvement of Tablets Validation Process in Pharmaceutical Industry.

Engineer’S Degree, Industrial Mechanical Engineering, Bachelor

Activities and Societies: >Technical Projects: VENTILATION, REFRIGERATION AND AIR CONDITIONING PROJECT - PORTABLE REFRIGERATION SYSTEM.

Bachelor’S Degree, Chemistry

Activities and Societies: Laboratory of Research in Electrochemistry (LaPE): Scientific Studies in Environmental Electrochemistry Bachelor.