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 able to 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.
Organización
Mam de la Frontera, S.A. de C.V.
Giro
Maquiladora (Export.)
Actividad principal
Maquila, shelter
Número de empleados
8000
**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