Highly motivated professional with high competence in the design, implementation and supervision of Quality Management Systems (ISO 13485, 21 CFR 820, NOM 251-SSA1, WRAP 12 Principles, C-TPAT, ISO 14001, ISO 45001) with 12 years of experience in textile manufacturing industry, food and services. Lead QMS auditor (ISO 9001:2015 & ISO 13485:2016) always driving continuous improvement by identifying failures or discovering possible opportunities, allowing the main managers of the organization to make decisions or reorientations based on the situation shown, and with them achieve their intended objectives.Accompany and provide support to companies in the process and contacts of registration in the FDA in Medical Devices and contacts of contracting and attention of certifying bodies in ISO 9001 & ISO13485.Worked with Internal and Corporate Auditors to conduct compliance audits, as necessary, to ensure that group companies work within established policies and procedures, applicable rules and regulations.Advice and support to companies to achieve successful third-party audits carried out by accredited bodies. Knowledge of cost system, inventory and personnel management in manufacturing processes and how to implement them to evaluate the performance of a company and to be able to implement corrective actions on time. I have designed and carried out tests, analyzes and validation protocols to medical device processes to maintain quality levels and minimize defects and failure modes, generating reports of defective products to determine trends, using concepts of probability and statistical quality control.I have identified and analyzed the risks and potential threats (FODA/ AMEF) in complete companies, specific or critical areas of different processes that have an adverse effect on the quality of the finished product, establishing priorities.Experience in the manufacturing of carbonated beverages for human consumption, water treatment for human consumption, preventive maintenance management of machinery and facilities, warehouse control of raw materials and spare parts, personnel management, annual budgets and costing.