Marcelo Dourado

Marcelo Dourado Email and Phone Number

Head de Qualidade e Assuntos Regulatórios Latam @ Align Technology
State of São Paulo, Brazil
Marcelo Dourado's Location
São Paulo, São Paulo, Brazil, Brazil
Marcelo Dourado's Contact Details

Marcelo Dourado work email

Marcelo Dourado personal email

About Marcelo Dourado

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.

Marcelo Dourado's Current Company Details
Align Technology

Align Technology

View
Head de Qualidade e Assuntos Regulatórios Latam
State of São Paulo, Brazil
Website:
aligntech.com
Employees:
12977
Marcelo Dourado Work Experience Details
  • Align Technology
    Head De Qualidade E Assuntos Regulatórios Latam
    Align Technology
    State Of São Paulo, Brazil
  • Align Technology
    Head Of Quality & Regulatory Affairs Latam
    Align Technology Jul 2022 - Present
    São Paulo, São Paulo, Brasil
    Líder 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.
  • Associação Brasileira Da Indústria De Tecnologia Para Saúde - Abimed
    Conselheiro De Administração Abimed
    Associação Brasileira Da Indústria De Tecnologia Para Saúde - Abimed Oct 2022 - Dec 2023
    São Paulo, São Paulo, Brasil
  • Philips Medical Systems
    Head Of Quality | Regulatory Affairs | Esg | Sustainability | Ehs
    Philips Medical Systems Jan 2021 - Oct 2021
    Brazil / Panamá
    Reporting 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.
  • Philips Medical Systems
    Head Of Quality Management Systems | Regulatory Affairs | Esg
    Philips Medical Systems Jan 2018 - Jan 2021
    Panamá
  • Philips
    Head De Qualidade | Assuntos Regulatórios | Esg - Latam
    Philips Aug 2014 - Dec 2017
    Brasil
  • Roche Diagnóstica Brasil
    Head Of Quality | Regulatory Affairs | Sustainability | Ehs
    Roche Diagnóstica Brasil Jan 2013 - 2014
    São Paulo / Brazil
    Report 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.
  • Roche Disgnostics
    Quality Management System And Quality Control
    Roche Disgnostics Mar 2008 - Dec 2012
    São Paulo, Brazil
  • Siemens Healthineers
    Quality Management Systems, Regulatory Affairs And Ehs
    Siemens Healthineers Nov 1998 - Feb 2008
    São Paulo, Brazil
    Project 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.
  • Kraus & Naimer Do Brasil
    Quality Engineer
    Kraus & Naimer Do Brasil Feb 1994 - Nov 1998

Marcelo Dourado Skills

Gmp Pharmaceutical Industry Medical Devices Fda Validation Quality Auditing Regulatory Affairs Process Improvement Iso 9000 Iso 14001 Capa Sustainability Health And Safety Advice Security Management Auditoria Da Qualidade Norma Iso 9000 Melhoria De Processos Garantia De Qualidade Seis Sigma Biotecnologia Quality System Strategic Planning Quality Assurance Microsoft Excel

Marcelo Dourado Education Details

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?

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

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.