Descripción y detalle de las actividades- Schedule: 7am-7pm Fri-Sun, 7a-4pm Mon - Participate in the execution of Quality functions in compliance with FDA QSRs, ISO 13485, ISO 14971, and other national and international quality requirements and standards. - Cross-Functional team member assisting in preparation and updates of manufacturing procedure documentation. - Support risk management activities related to manufacturing processes such as pFMEA. - Review and assist in writing new procedures and work instructions or updating existing documents to drive process improvement. - Evaluate and monitor manufacturing issues, and product concerns, and help investigate non-conforming material to determine opportunities for improving manufacturing and product performance. - Support Incoming Inspection activities, update procedures, forms, methods and training - Performing internal audits and assistt in hosting external audits.Experiência y requisitos- B.S. in Engineering or Science, or equivalent technical field. - 1-3 years in Medical Device Manufacturing or other regulated industry. - Ability to successfully and effectively fluently communicate verbally and written in English and Spanish - Patient/Customer Focused Quality perspective. - Working knowledge of QMS standards like ISO 13485 and familiarity with Risk management standards like ISO 14971 - Ability to work as a team or independently in a changing, fast-paced, deadline-driven environment; must be driven and ableto accept new challenges and continually strive for improvement in the support of effective therapy delivery to the patient and a delighted user experience. - Working knowledge of statistical techniques. - Working knowledge in spreadsheets, databases, and word processing software programs. - Strong attention to detail. - Highly organized. - Employ an engaged, collaborative mindset with teammates within the RA/QA department, as well as during frequent project interface with interdepartmental (Manufacturing Engineering, Production) colleagues.OrganizaciónMam de la Frontera, S.A. de C.V.GiroMaquiladora (Export.)Actividad principalMaquila, shelterNúmero de empleados8000**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** : 7am-7pm Fri-Sun, 7a-4pm Mon**Estudios** Carrera Profesional**Inglés **Hablado: 90%, Escrito: 90%**Sexo** Indistinto