Quality Engineer (Experiencia En Empresa Medica)

Review systems and processes to develop continued improvements through data analysis.- Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.- Analyzes and performs failure analysis (investigations) to non-conforming products.- Leads in the implementation of assurances, process controls, nonconformances and CAPA.- Support process validations for manufacturing process. (IQ, OQ or PQ).- Develops and prepares monthly quality trend analysis and reports.- Excellent interpersonal skills.- A self-starter, motivated and able to positively motivate others.- Focused, target driven with a positive, can-do attitudeBachelor's degree in engineering or technical field or equivalent experience is required. **Minimum of 5 years of quality experience in a medical device or other regulated industry is required. ** Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. **Able to read and understand technical data (drawings, GD&T, etc) ** Competent using Microsoft Office suites. **Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology. ** Ability to multi-task and manage multiple assignments in a timely manner. **Good communication and interpersonal skills. ** Strong analytical skills. **Sound knowledge of FMEA. ** Green Belt certification or equivalent a plus.English : 90%Certifications**:SIX SIGMA, GREEN BELT CERTIFIED 21 CFR PARTE 820 Auditor certificado ISO 13485 GMP's para Dispositivos Médicos RISK MANAGEMENT ISO 14971**Skills: - Manejo, Resolucion de conflictos y estrés laboral Elaboración de FMEA ¨sTipo de puesto: Tiempo completoSalario: $1,000.00 - $1,500.00 al díaHorario:- DiurnoPregunta(s) de postulación:- Cual es su nível de Inglés ?- Cuenta con Visa Vigente?- ¿Cuántos años de experiência tienes en empresa medica?Experiência:- QUALITY ENGINEER: 1 año (Deseable)