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)- Lead Auditor certification a plus.- Competent using Microsoft Office suites.- Experience with statistical analysis software a plus.- 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.- Must be able to communicate fluently in both written and spoken English.- Strong analytical skills.- Sound knowledge of FMEA.- Sound knowledge of sampling plan and other statistical techniques.- **Experience (desired) on**: o Environmental and microbiological testing, such as non-viable and viable particles counting. o Cleanroom environment sustaining. o Sterilization concepts and product release. o Contractor´s management, such as external laboratories and sterilization sites.- 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.**Languages**: English : 90%Tipo de puesto: Tiempo completoSalario: $2,000.00 - $3,000.00 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)
