Industrial Engineer, with great interest in working in the areas of analysis and continuous improvement of processes, management systems, quality, project evaluation, planning and production control.
Be responsible for maintaining the quality of medical devices before the INVIMA health authority. Report adverse events to Technovigilance periodically or when required. Self-inspect the compliance of the system in the production process of the medical device and guarantee its continuous improvement, through its monitoring and control.
Major achievementDevelop and implement the process of risk medical device I (Tapabocas) in the company, complying with the legal requirements of decree 4725 of 2005 and resolution 4816 of 2008, designing the production process, its documentation and its quality system.
Projects of improvement and implementation of processes and certifications, preserving the integration of management systems, creation and management of organization management indicators, monitoring of strategic analysis, development and implementation of internal improvement projects from planning to management of Orders that increase the profitability of the business and the agility of the processes, directing the group of the quality area as head of the same.
Major achievementMaintain the ISO 9001: 2015 certification of the company as the project leader. Improvement of the productive area according to GMP guidelines to improve the INVIMA sanitary concept. Be part of the ERP implementation group in the company and software development for the company.
Carry out traceability to the different processes that the company has to carry out continuous improvement, improvement projects and implementation of processes and certifications of the Quality system, protection of the documented information of the quality management system, group management of the quality area as head of the same and attend customer complaints.
Major achievementObtain the certification of the company in ISO 9001: 2015 as project leader and responsible to the certifying body. Improvement of the production area according to BPM guidelines to obtain the INVIMA concept. Be the leader of a work group of 10 people (quality area).