Maintenance and improvement of the QMS per ISO 9001 2015 Process enhancement with departmental leaders, employing KPI and OKR metrics for continuous improvementImplementation of ISO 27001 2022

QMS Auditor - Quality Management - Medical Devices

In charge of the maintenance of the QMS proccesses in Argentina. Actually leading the implementation of ISO 13485 across LATAM: Chile, Colombia, Peru, and MexicoImproving and mapping all processes within KSDesigning flow layouts in workspace areasInvolvement in Continuous Improvement projectsOverseeing Regulatory Affairs for the entire LATAM regionProviding support to all sectors in implementing Quality ImprovementsMonitoring all Quality IndicatorsAssisting the… Show more In charge of the maintenance of the QMS proccesses in Argentina. Actually leading the implementation of ISO 13485 across LATAM: Chile, Colombia, Peru, and MexicoImproving and mapping all processes within KSDesigning flow layouts in workspace areasInvolvement in Continuous Improvement projectsOverseeing Regulatory Affairs for the entire LATAM regionProviding support to all sectors in implementing Quality ImprovementsMonitoring all Quality IndicatorsAssisting the board in matters related to Safety and Hygiene, and Environmental issuesAchievements:Successfully obtained ISO 13485 certification for branches in Chile and Peru.1 Quality Analyst in charge Show less

Redaction, control, and monitoring of all necessary documents for the QMS under ISO 13485:2016.Quality control at all stages of the production process.Implementation of 5S.Monitoring and improvement of quality indicator boards to add value to processes.Training for different sectors, promoting a culture of quality and knowledge of the QMS.Handling complaints and evaluating customer satisfaction by measuring quality parameters in collaboration with the customer service… Show more Redaction, control, and monitoring of all necessary documents for the QMS under ISO 13485:2016.Quality control at all stages of the production process.Implementation of 5S.Monitoring and improvement of quality indicator boards to add value to processes.Training for different sectors, promoting a culture of quality and knowledge of the QMS.Handling complaints and evaluating customer satisfaction by measuring quality parameters in collaboration with the customer service department.Management of non-conformities, non-conforming products, supplier audits, and quality support in the search for new technologies.Collaboration with the Production department in the validation and verification of new processes, equipment, and products.Acting as a liaison between all areas to achieve quality objectives based on the defined quality policy.Training and process implementation throughout KS LATAM. Support in accreditations.Participation in the layout diagram of the plant.Achievement: Obtained ISO 13485 - Quality Management Systems for Medical Devices certification.1 Quality Analyst in charge Show less

Drafting and control of documents under the FSSC 22000 standard. Quality control of the production processes based on the designed HACCP. Process mapping. Traceability. Complaints management and handling of non-conformities. Daily plant inspections. Training for staff, both routine and induction, on topics related to the quality and food safety.

Control and verification of Good Manufacturing Practices (BPM), Sanitation Standard Operating Procedures(POES), and Hazard Analysis and Critical Control Points (HACCP).Quality control of processesDevelopment and implementation of manuals, procedures, records, and instructions under ISO 9001:2015Staff trainingSupplier controlCollection and analysis of microbiological samplesReception of external auditsComplaint managementProduct recallTreatment of… Show more Control and verification of Good Manufacturing Practices (BPM), Sanitation Standard Operating Procedures(POES), and Hazard Analysis and Critical Control Points (HACCP).Quality control of processesDevelopment and implementation of manuals, procedures, records, and instructions under ISO 9001:2015Staff trainingSupplier controlCollection and analysis of microbiological samplesReception of external auditsComplaint managementProduct recallTreatment of non-conformitiesInternal quality audits and supervision of cafeterias located in the industrial park of Bahía Blanca.Achievements: Obtained ISO 9001:2015 certification. Show less

Execution of quality, food safety, and HSSE audits.Verification of Good Manufacturing Practices, SSOP, HACCP, Pest management.Loading reports and sampling on a freelance basis for Diversey.Clients:Walmart SupermarketsChango Más SupermarketsCarrefour SupermarketsMakro HypermarketsYPF Service StationsFood Services Compass Group (White Gulf S. A.)

Internship at UNS for 3 months:Preparation of culture media.Determination of sulfites in shrimp.Conducting microbiological analyses on samples of water, food, and surface swabs for the detection of microorganisms.Drafting procedures and instructions under ISO 17025.