Descripción y detalle de las actividades
The Quality Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals 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. Key Tasks & Responsibilities: -Liaises with Quality teams of other sites in the coordination of tasks and activities at the plant. -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 ABLLC: Receiving Inspection and Quality control to ensure a streamlined manufacturing process is maintained. -Supports 3rd party audits regarding manufacturing processes and policies. -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 (Engineerin, Marketing, Clinical, and Regulatory) for investigations. -Ensure product meets and exceeds product specifications, regulatory requirements, and international standards. -Assitss for various testing planning, execution and reporting, IQ, OQ, PQ. Verification and Validation of manufacturing processes, equipment and tooling etc. -Participates in the investigations and dispositions of product, non-conformances and changes, CAPA, NC, MRB. -May create and/or deliver training per company and international standard requirements -May mentor, train or otherwise provide guidance to team members as required, leveraging product skills and experience -QA representative on cross functional teams, GEMBA walks, Manufacturing Kaizen Events (when applicable -Support other duties as assigned -Participate as lead auditor/team member during internal audit
Experiência y requisitos
B.S. in Engineering or related technical discipline. Training in some or all of the following: - ISO 13485:2016 Lead auditor Certificate - Six-Sigma. - Lean Principles - Solid knowledge of relevant regulations and guidance related to design assurance - Proven ability to work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence. - Demonstrated technical communication skills (both written and oral). -Proficient in Microsoft Office suite, Minitab or equivalent statistical software Desirable: - ASQ certification -Experience using Agile PLM
Organización
Sonova
Correo de contacto
Giro
Manufacturera
Actividad principal
Proveedor de soluciones de cuidado auditivo - Dispositivos Médicos
Número de empleados
800
Aviso de privacidad
- /mexico/es/politica-de-privacidad-de-la-web-y-cookies**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera Profesional
**Inglés **Hablado: 80%, Escrito: 80%
**Sexo** Indistinto