Descripción y detalle de las actividadesResponsible for compliance to procedures and regulations for Manufacturing Controls of the Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO 13485, ISO 14971, MDSAP and MDR. - Provides status reporting regarding manufacturing processes deliverables, dependencies, risks and issues, communicating across teams and to direct management. - Assists in managing all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives - Partners with Operations: Receiving inspection, Quality control and supplier quality to ensure a streamlined manufacturing process is maintained. - Supports 3rd party audits regarding manufacturing processes and policies - Provides expertise to the manufacturing and design team on the implementation of international standard requirements (ISO 14971, ISO 13485, particular standards, etc.) as they relate to manufactured product. - Identification and interpretation of recognized standards for medical manufacturing (e.G. ISO 13485, 21 CFR 820, MDSAP, EUMDR etc.) - Assists Quality in the support of stake holders (Engineering, Marketing, Clinical, and Regulatory) for investigations, etc. - Ensure product meets and exceeds product specifications, regulatory requirements, and international standards - Responsible for various testing planning, execution and reporting, IQ, OQ, PQ. Verification and Validation of manufacturing processes, equipment and tooling etc. - Recommends process improvements to management and executes to ensure consistent implementation of internal requirements and external regulations and standards. - Participates in the investigations and dispositions of product, non-conformances and changes, CAPA, NCMR, MRB - As needed, prepares documentation for and supports regulatory submissions (USA, EU, International).Experiência y requisitosOrganizaciónSonovaCorreo de contactoGiroManufactureraActividad principalProveedor de soluciones de cuidado auditivo - Dispositivos MédicosNúmero de empleados800Aviso de privacidad- /mexico/es/politica-de-privacidad-de-la-web-y-cookies**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** 8:00 am - 5:30 pm**Estudios** Titulo Profesional**Inglés **Hablado: 85%, Escrito: 85%**Sexo** Indistinto