.Descripción y detalle de las actividadesWhat you'll be doing Ensure compliance with QSR part 820, ISO-13485 and other applicable regulations. Implements, monitors, improves and reports on metrics to monitor Quality performance. Ensure that the non-conforming material process is executed in accordance with established procedures and in compliance with determined metrics. Leads/oversees validation activities, IQs, TMVs, OQs, PQs, for designated areas Ensures that the validated status is maintained during any decision-making process. Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives. Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness. Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report. Participates or leads project transfer, through the identification and closing of gaps from the quality system and manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines Participate in Value Stream projects (quality improvements, cost savings, productivity gains). Ensure that all inspection and test specifications are properly performed and documented. Conduct a root cause analysis to prevent recurrence. Supervise that all personnel reporting to him/her are adequately trained for the functions they perform. Conducts routinary internal audits, Gembas, LTTs of the quality system in compliance with procedures. Reports audit results to management. Supervise and coordinate the function of the Quality Technicians, Quality Intern and Quality Eng C. Ensures compliance with assigned KPIs and notifies management of any possible impact Ensures that subordinates' duties and responsibilities are clearly defined and that performance is routinely measured and reviewed. This includes: Definition of performance standards and related objectives; Experiência y requisitosWhat you'll bring Excellent verbal and written communication skills (English/Spanish) Bachelor's degree Personnel Management Training - Knowledge on risk management ISO 14971 QSR Part 820 Training / Awareness and ISO13485 Root cause Analysis Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc. (Deseable) Desired Knowledge in medical device regulations and standards, including FDA medical device regulations covered by Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC / EU MDR Quality Eng certified by ASQ (Deseable) Green Belt Six Sigma Certified
