Quality Engineer (Medical)

Minimum of a bachelor's degree (BS) in engineering from a four year college or university- Good written and verbal communications skills English and Spanish- Preferred experience in medical device industry.- 3-5 years related experience in similar positions- Knowledge of ISO 13485- Domain of root cause analysis tools- Capable of Leading MRB board- Ability to administrate calibration of equipment.- Ability to collect and present Data per the established metrics.- Experience in developing inspection methods, establishing sampling plans, interpreting customer specifications, TMVs, GR&R, etc.- Able to challenge processes and work with engineering department to develop manufacturing documentation and validation documents (IQ, OQ, PQ)- Participate in development of new products, coordination of NPWOS, SWOs (trials for new products)- Knowledgeable in Statistical tools- Development of Quality plans, Control plans and Risk files- Selection, hiring and training of quality personnel. Provides direction and management of daily activities for quality technicians.- Familiarity with CAPAS, CO's, DHRs, PFMEAsTipo de puesto: Tiempo completoTipos de compensaciones:- Bono de asistencia- Bono de puntualidad