**_Job Descripition _**Oversees and directs plans, organizes and develops test plans, prepares test data and subsequent testing of all products.Responsible for managing data during product development and evaluation prior to product release.**_Activities _**1) Responsible for customers, ISO audits, and for organizing compliance to regulatory requirements related to manufacturing medical devices.2) Develop and documents quality plans for new and existing products.3) Monitor and controls quality systems to ensure effectiveness, efficiency and compliance.4) Manage incoming raw material inspection procedures and personnel.5) Analyze quality control test results and provides feedback and interpretation to production management or staff.6) Support manufacturing and engineering problem solving efforts on in-process and vendor related quality issues.7) Communicate quality control information to all relevant organizational departments, outside vendors and contractors.**_**_- *Requierements_*Strong people management and development skills.Strong listening skills.Bachelor's degree or equivalent in quality, operations management or engineering related field.A minimum of 10 years experience in manufacturing medical with at least 5 years in a management and/or supervisory capacity.Proven experience within a medical device manufacturing and governmental regulations and standards ( ISO13485, MDR).Certified Quality Engineer.Demonstrated ability implementing world-class quality management practices to drive continuous improvement throughout the quality systems.Experience in data analysis.Experience in FDA and ISO regulations applied to Medical industry.Tipo de puesto: Tiempo completoSalario: A partir de $110,000.00 al mesBeneficios:- Aumentos salariales- Caja de ahorro- Descuentos y precios preferenciales- Días por enfermedad- Estacionamiento de la empresa- Estacionamiento gratuito- Horarios flexibles- Seguro de gastos médicos- Seguro de gastos médicos mayores- Seguro de la vista- Seguro dental- Seguro de vida- Servicio de comedor- Servicio de comedor con descuento- Teléfono de la empresa- Vales de despensaHorario:- Diurno- Horario flexible- Lunes a viernes- Turno de 10 horas- Turno matutinoPago complementario:- Bono anual- Bono de productividad- Bono trimestralConsideraciones ante el COVID-19:- Mascarilla.- Careta.- Monitoreo de temperatura al entrar y salir de las instalaciones.- Tapetes sanitarios y gel distribuida en todas las instalaciones.- Pruebas de PCR para personal con sintomas.Educación:- Licenciatura terminada (Obligatorio)Experiência:- Sistemas de calidad: 10 años (Obligatorio)Idioma:- Inglés (Obligatorio)Trabajar desde casa:- No