Global Quality Analyst

Descripción y detalle de las actividadesSummary: Responsible to create periodic reports on internal and external audits, Quality Operations metrics, product quality trends, quality system activities, and other information as required. Act as Subject Matter Expert on CAPA, providing training on CAPA and investigation tools and techniques. Other duties as assigned. - Generate monthly global audit calendar and audit report. - Analyze audit results for repeat and systemic findings. - Prepare monthly Quality Operations metrics for global L-1 and other report-outs. - Develop and maintain a CPM dashboard. - Work with site leaders to improve the quality and timeliness of CAPA. - Conduct training for sites on investigation principles and practices, as needed. - Assist in the writing of QMS procedure revisions, as needed.Experiência y requisitos- College or University degree - 2 years experience in medical device or pharmaceutical manufacturing, preferably in a Quality role - Conversational English, spoken and written. - Familiarity with common MS Office tools, particularly Excel; willingness and abilityto learn Agile. - Knowledge of ISO13485, 21CFR820, EUMDR requirements.OrganizaciónENOVIS México, S.A. de C.V.GiroMaquiladora (Export.)Actividad principalManufactura aparatos ortopédicos.Número de empleados2700**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto