Livia Mara De Souza

Experience

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  Alcoa

  Jul 2006 - Sept 2006

  Intern

  - Internship in the Quality and Planning of Refinery Area.- Worked with DMS - Daily Management System.- Implemented OEE analysis.- Developed the VSM - Value Stream Map - of Refinery Process.

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  BD

  Oct 2006 - Dec 2007

  Process Engineer

  - Development of Statistical Process Validation in the production lines.- Coaching of Six Sigma Projects - Green Belt Projects.- Development of Statistical Process Control (SPC).- Analysis and answering of consumer complaints.- Created and revise SOP.- Followed auditing process and developed action plans to solve nonconformities.

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  Mondelēz International

  Jan 2008 - Nov 2014

  - Quality Brazil leader in the implementation of a new Quality System.- Implement and consolidate a new Quality System for process control and automated form register in all Brazil Plants. This new system utilizes the software InfinityQS as the main tool.- Guarantee the alignment among Brazil Plants in using InfinityQS to make Quality and Manufacturing data register. By this software, all forms of process control, statistical process control, pre/pos operational checklists, HACCP and labs data will be transfered from paper form to automated form. Show less

  • Quality Coordinator

    Oct 2013 - Nov 2014

  • Continuous Improvement Specialist - Black Belt

    Jan 2009 - Sept 2013

  • Manufacturing Trainee

    Jan 2008 - Dec 2008
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  Silimed Indústria de Implantes

  May 2015 - Mar 2016

  Lean Six Sigma Specialist - Black Belt

  Development of Six Sigma projects focused on re-structuring Quality Management System. One project with the objective of revising, simplifying and optimizing breast implant manufacturing documentation (procedures, forms, tables). Another project was to improve and implement a better control of visual inspection in breast implant process (utilize MSA – Measurement System Analysis).

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  Johnson & Johnson

  Apr 2016 - Sept 2016

  Quality Assurance Operations Supervisor

  - Quality Operation Supervisor focused on Needle and Catgut Plants that supply suture manufacturing raw material. - Team leader of 4 Quality Engineers and 2 Quality Analysts dedicated to process quality improvement, non-conformance analysis, failure investigation, process and quality indicators trend analysis, creation and revision of process and quality procedures, lean and six sigma projects, attend internal and external audits and also support on process, cleaning and test method validation. Show less

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  Philips

  Jul 2018 - Jun 2021

  - Responsible for leading Q&R activities related to Design Control & SDLC (Software development life cycle) for both medical device & non-medical device software products in Philips EMR portfolio, guaranteeing product quality delivery and compliance to all certified standards and regulations (ISO 13485, EU MDR, ISO 9001, IEC 62304). - Quality support on localization programs for new markets and ensure compliance on all product maintenance activities as well.- Coach on continuous improvement programs in Philips EMR like Kaizen, Daily Management and Problem Solving. Show less - Quality SME for Supply Chain, Design Control and CSV (Computer System Validation) of EMR Business Category (Electronic Medical Record).- Support on the analysis and implementation of Philips HI (Healthcare Informatics) procedures.- Process update and maintenance in order to be compliant to ISO 13485:2016, ISO 9001:2015 and EU MDR.- Analysis and resolution of CAPA and non-conformances.- Coaching on Continuous Improvement initiatives such as Kaizen, Daily Management, PDCA and tools for data analysis and Problem Solving. Show less

  • Quality Manager

    Apr 2020 - Jun 2021

  • Quality Specialist

    Jul 2018 - Mar 2020
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  3M

  Jul 2021 - now

  Quality Assurance Supervisor