Post-graduation in Quality and Productivity with a focus on Industry 4.0 and post-graduation in Production Engineering. Professional experience as coordinator of the Quality Management System ISO 13485: 2016 Health products - Quality management systems - Requirements for regulatory purposes; MDR 2017/745 - European Medical Device Regulation, RDC 16/2013 Good Medical Device Manufacturing Practices and ISO 19011: 2018 - Management Systems Audit Guidelines, responsible for Tecnovigilance. Educational instructor in the areas of Industrial Management, Logistics, PCP, Quality, People Management, Food Safety - Food Microbiology. Trainings and lectures in companies for national and multinational companies. Sanitation, Clean Room and Packaging Supervisor. Responsible for industrial management and development of technologies related to the product. As a graduate in Biological Sciences - Licenciatura, Researcher of Bone Growth Induction for Implantation of Medical Devices and Biomaterials. Internal audit of the 5S Program; Auditor of the Business Excellence Award. Professional Life and Career Coach.
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Consultora Em TecnologiaSenai BauruBauru, Sp, Br
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Consultor Em TecnologiaSenai Bauru Nov 2022 - PresentBauru, São Paulo, Brasil -
Proprietária De EmpresaCarol Hee - Desenvolvendo Pessoas E Negócios 2020 - Nov 2022
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Quality Assurance CoordinatorAlliage S/A Jun 2019 - Apr 2020Ribeirão Preto, Sp, Brasil- Quality Assurance Coordinator for medical devices Responsible for planning and managing the area of quality management and regulatory systems, aiming to ensure the regulatory and legal requirements related to all business units of the company. RDC 16: 2013 Good Manufacturing Practices for Medical Devices ISO 13485: 2016 Health Products - Quality Management Systems - Requirements for Regulatory Purposes MDR 2017/745 - European Medical Devices Regulation - Quality Assurance Coordinator for Dental Implants Project document management, implant team and processes through compliance with product quality standards and regulations. Process validation and environmental monitoring in Clean room. -
Professional Instructor IiSenai Feb 2013 - Jan 2017Bauru Area, BrazilInstructor in Technical courses, Qualification and Improvement; Training and Consulting in national and multinational companies; Auditor of the Business Excellence Award Year 2016; Mentoring for WorldSkills competitors; Technical and motivational lectures; Participation in the Mundo SENAI; Contribution with technical articles and interviews for newspapers and books; Results obtained: reduction in evasion rate; increase in frequency index; opening for new companies. -
Clean Room SupervisorPi Branemark Aug 2008 - Mar 2013Bauru Area, BrazilActing in the area of Dental Implants, Prosthetic and Instrumental Components;Control of Productive Processes;Control and monitoring of Production Indicators;Elaboration of Procedures of the Quality Management System;Participation in Internal and External Audits (Certification of RDC 59 - ANVISA);Analysis of Reports: microbiological water, chemicals, Clean Room Validation, sterilization validation (Bioburden and sterility);Structuring and Control of Work Environments.Results obtained: increased productivity through process restructuring and continuous team training. Development of new technologies for the intermediate packaging process of the product. Reduction of costs related to overtime. Team engagement and organizational climate conducive to new ideas. -
Research And DevelopmentBionnovation Biomedical Jun 2004 - Oct 2006Bauru Area, BrazilProcessing of dental and instrumental implants in a chemical laboratory; Research and Production of biomaterials; Research and development of new products in this segment; Study and application of ISO 10993 - Biological Evaluation of Medical Devices; Participation in Internal and External Audits (Certification of RDC 59 - ANVISA); Hydroxyapatite Project - Synthetic Bone in Laboratory; Structuring of Clean Room and Biomaterials Laboratory; Research with Application of Bone Induction Proteins for Ectopic Activity (Scientific Initiation).
Hee, Ana Carolina Skills
Hee, Ana Carolina Education Details
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Education | Technology | Communication -
Engenharia De Produção -
Quality And Productivity -
Biology/Biological Sciences, General -
Professional And Life Coaching
Frequently Asked Questions about Hee, Ana Carolina
What company does Hee, Ana Carolina work for?
Hee, Ana Carolina works for Senai Bauru
What is Hee, Ana Carolina's role at the current company?
Hee, Ana Carolina's current role is Consultora em Tecnologia.
What schools did Hee, Ana Carolina attend?
Hee, Ana Carolina attended Universidade Católica De Brasília, Universidade Estadual Paulista 'júlio De Mesquita Filho' / Unesp, Centro Universitário Do Sul De Minas, Unisagrado, Uninove, Slac Coaching.
What skills is Hee, Ana Carolina known for?
Hee, Ana Carolina has skills like Microsoft Excel, Microsoft Office, Quality Systems, Excel, Microsoft Powerpoint, Microsoft Word, Team Leadership, Logistics, Iso, Sistema De Qualidade, 5s, Metodologia Kaizen.
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