Marcelo Dourado Email and Phone Number
Marcelo Dourado work email
- Valid
- Valid
Marcelo Dourado personal email
- Valid
Executive with consolidated national and international career developed in the areas of Quality Management System and Quality Assurance, Regulatory Affairs and ESG. Experience in large multinational industries in the medical, pharmaceutical, electronics segments. Know how to conduct strategies and implement large projects, change sites, implement CSC (Shared Services Center) and strategic solutions, with the aim of improving processes, reducing costs and enabling sustainable and profitable projects.Expertise in feasibility analysis for new investments, compliance with strategic planning, schedule management and definition of the main KPI's. Development of relationship with stakeholders, aiming at projects with greater sustainability, to understand the needs, risks and opportunities, as well as adapt the best solutions to the business.Responsible for QA review, approval, and Quality operational oversight of internal manufacturing documentation, defining and agreeing on the follow up of CAPA’s from changes and deviations during all processes.Mindset aimed at stimulating the culture of QA & RA (Quality and Regulatory). Actions to mitigate compliance risks, improve corporate governance, involving leaders in managing changes and implementing compliance policies.Strong team management skills, communication skills and connection of strategic objectives with team engagement and motivate team to achieve goals and results. Communication skills with diverse cultures and adaptability to lead national and international projects in countries and regions such as the United States, Europe, Asia and LATAM. Constant study of global scenarios, regional legislation and regulatory bodies to adapt the business through agile solutions in highly complex scenarios.Participation in executive boards and internal committees and Company Representative as board members in Trade Associations.Strong knowledge and application of tools and methodologies such as Lean, risk assessments, continuous improvement, TrackWise, quality management tools and SAP and Salesforce systems.
Align Technology
View- Website:
- aligntech.com
- Employees:
- 12977
-
Head De Qualidade E Assuntos Regulatórios LatamAlign TechnologyState Of São Paulo, Brazil -
Head Of Quality & Regulatory Affairs LatamAlign Technology Jul 2022 - PresentSão Paulo, São Paulo, BrasilLíder para latam nas áreas de Assuntos Regulatórios, Garantia e Sistemas de Gestão da Qualidade. Responsável pela estratégia regional para produtos (time to market). Liderar e suportar regionalmente o Sistema de Gestão da Qualidade, com base na ISO 13485 e regulamentações locais (ANVISA, Cofepris, ANMAT, INVIMA, etc) e outros requisitos regulamentares globais e Auditorias MDSAP. -
Conselheiro De Administração AbimedAssociação Brasileira Da Indústria De Tecnologia Para Saúde - Abimed Oct 2022 - Dec 2023São Paulo, São Paulo, Brasil -
Head Of Quality | Regulatory Affairs | Esg | Sustainability | EhsPhilips Medical Systems Jan 2021 - Oct 2021Brazil / PanamáReporting to the VP of Quality & Regulatory Affairs in the Netherlands and to the CEO LATAM. Expatriation to Panama from 01/2018 to 12/2020. People management, monitoring the backlog, approvals and conducting strategic actions with the team. Member of Philips LATAM Executive Committee.Company Representative as Advisor at ABIMED and ABIMO(Board Member). Maintenance and implementation of medium and long-term compliance, regulatory and quality policies. Development of actions in multidisciplinary teams to increase the level of awareness and culture of QA & RA (Quality & Regulatory). Management of compliance with FDA regulations, ISO 13485, ISO 9001 and the standards of other regional Regulatory Agencies (Good Manufacturing Practicies). Management of customer complaints handling, post-market surveillance, nonconformity and CAPA (Corrective Action and Preventive Action). Management of manufacturing inspections and audits, products, records, product recall activities, LATAM Audit program and processes. Monitoring of results, analysis of KPIs and compliance with costs in the area. Restructuring of the Regulatory area, including Regulatory Intelligence. Relationship with regulatory bodies and trade associations in Latam level (regional). To identify risks for complex regulatory strategies and analyze local regulatory trends and market intelligence. To develop RA relationship with Distributor RA counterparts and supports Distributor RA activities. Cost reduction projects, deadlines, risks and impacts and insertion of the policy for NPI (New Product Introduction) in the market and MDSAP Audit. Support the organization on creating a culture of continuous improvement / LEAN.Environmental management of contaminated soils (Soil Remediation) and decontamination of sites in accordance with Environmental Policies and reverse logistic process. Reorganization of the EHS area and implementation of E-social in the company. -
Head Of Quality Management Systems | Regulatory Affairs | EsgPhilips Medical Systems Jan 2018 - Jan 2021Panamá -
Head De Qualidade | Assuntos Regulatórios | Esg - LatamPhilips Aug 2014 - Dec 2017Brasil -
Head Of Quality | Regulatory Affairs | Sustainability | EhsRoche Diagnóstica Brasil Jan 2013 - 2014São Paulo / BrazilReport to Brazil CEO. Responsible for Regulatory Affairs and Quality Management System, Pos Market Surveillance - Aftermarket, Risk Management, Quality Assurance and Waste Management areas. Management of multidisciplinary teams and support to the team in the development of projects. Establish and implement the overall vision, objectives and strategy for Brazil Regulatory initiatives.Lead the ISO 9001 Quality System Cetification in Brazil.Leader in improvement projects, increase in the profitability and use of tax benefits (ICMS). Complaints management and implementation of Divisional Standards and Policies, as well as the Business Continuity Plan. Execution of strategic planning, budget, and investments for new projects. Manage Latam QA RA team, ensuring clarity around priorities and goals, planning the required resources to meet objectives. Constant analysis of KPIs.Ensures the Good Manufacturing Practices mandated by country regulator (ANVISAl) are appropriately documented through QMS.Manage internal audits in accordance with documented requirements and timelines. -
Quality Management System And Quality ControlRoche Disgnostics Mar 2008 - Dec 2012São Paulo, Brazil -
Quality Management Systems, Regulatory Affairs And EhsSiemens Healthineers Nov 1998 - Feb 2008São Paulo, BrazilProject management and all relevant actions in the Regulatory area and product registration with ANVISA. Strong leadership role in project execution and in the development of high-performance teams. Monitoring of costs, budget management, elaboration of the strategic plan, analyzes aimed at improving profitability and sustainability for the business. Participation as Advisor of ABIMED (Board Member). Leader in process improvement projects and related to tax incentives. -
Quality EngineerKraus & Naimer Do Brasil Feb 1994 - Nov 1998
Marcelo Dourado Skills
Marcelo Dourado Education Details
-
Engenharia Elétrica E Eletrônica -
Instituto Brasileiro De Governança CorporativaConselheiro Administrativo -
Business/Commerce, General -
Qualidade E Produtividade
Frequently Asked Questions about Marcelo Dourado
What company does Marcelo Dourado work for?
Marcelo Dourado works for Align Technology
What is Marcelo Dourado's role at the current company?
Marcelo Dourado's current role is Head de Qualidade e Assuntos Regulatórios Latam.
What is Marcelo Dourado's email address?
Marcelo Dourado's email address is ma****@****ips.com
What schools did Marcelo Dourado attend?
Marcelo Dourado attended Universidade Presbiteriana Mackenzie, Instituto Brasileiro De Governança Corporativa, Fundação Getulio Vargas, Universidade De São Paulo.
What skills is Marcelo Dourado known for?
Marcelo Dourado has skills like Gmp, Pharmaceutical Industry, Medical Devices, Fda, Validation, Quality Auditing, Regulatory Affairs, Process Improvement, Iso 9000, Iso 14001, Capa, Sustainability.
Who are Marcelo Dourado's colleagues?
Marcelo Dourado's colleagues are Dan Ellis, Rebecca Cho, Oren Hazan, Jose Fabio Sandi Sandoval, Juan Hernández Zdo., Bala Nagendra Reddy, Irene B..
Not the Marcelo Dourado you were looking for?
-
-
Marcelo Dourado
Especialista Em Agronegócio/ Representante Comercial/ Barter/ Comercialização De Grãos/ Gerenciamento De Risco/ Crédito Rural E CusteioRedenção, Pa -
Marcelo Dourado
Fortaleza, Ce -
2gmail.com, cognizant.com
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial