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