Luiz Felipe S.

Experience

• 

  Titaniumfix

  Jun 2010 - now

  Engineer in the project department responsible for:- Managing risk management activities;- Coordination of multidisciplinary and engineering teams;- Developments for product designs and processes under the state of the art;- Issuing and reviewing specifications, reports, project validations, rationales and other documentation of design history file (DHF);- Supporting technical areas through expertise in standardisation, critical and systemic analyzes for continuous improvement processes;- Preparing and reviewing documentation for the QMS, as well as audit or participate in external audits and sanitary inspections;- Representing the company at technical and regulatory events. Show less Engineer in the quality department responsible for: - Managing risk management, testing and validation activities; - Technical developments for new projects or improvement of products and processes;- Controlling and ensuring the quality of products and processes; - Preparing and controlling the QMS documentation, ISO 9001, ISO 13485 and CE Marking quality certifications;- Investigation and issuing reports on customer complaints and non-conformities;- Development and preparation of technical and regulatory documentation, as well as participate in audits and sanitary inspections; - Representing the company in technical and regulatory events. Show less Engineering trainee in the departments of: - Process engineering: responsible for controlling of PPC, productive efficiency analysis, development and improvement of surgical instruments machining processes - eight months. - Project engineering: responsible for planning and execution of projects, preparation and revision of technical documents, mechanical tests, studies about materials and improvements for medical devices - two years and one month. - Quality: responsible for planning and execution of mechanical, chemical, physical-chemical, microbiological and biocompatibility tests. Preparation and controlling of validation testing and related technical documentation. Team member to quarantine team for analysis of customer complaints - ten months. Show less

  • Design Engineer

    Oct 2022 - now

  • Quality Engineer

    Feb 2014 - Oct 2022

  • Engineering Trainee

    Jun 2010 - Jan 2014