Quality Engineer
hace 7 meses
Descripción y detalle de las actividades
Purpose of the position: Quality Engineer will be responsible for leading refurbish quality operation processes. In addition, this position will drive product and process improvements through root cause analysis and statistical analysis, triggered by customer complaints, CAPA, nonconformance, internal and external audits, KPI metrics, and/or management review. Key Tasks & Responsibilities: - Works with multidisciplinary teams within Sonova to manage problem solving and improvement projects and initiatives - Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products. - Develops and implements procedures, work instructions, process descriptions and other documented solutions related to the quality management system - Coordinates, conducts and documents product quality inspections - Conducts external and internal audits - Leads quality related meetings - Coordinates and facilitate training as required - Work with in-house ERP, CRM, DMS systems and other databases - Use risk approach for decision making - Generate reports, metrics, KPI aiming to monitor processes and drive continuous improvement
Experiência y requisitos
- BS in an Engineering, Science, or related field required. Desirable: -ASQ Certification (CQE, CQM, CSSBB, CQA, or other) desired -Certification in internal audit for ISO 12385, ISO 9001 desired Required: - Experience with process/production line transfers. - Strong organizational skills - Strong verbal and written communication skills - Good project management skills: capable of effectively managing multiple projects and objectives concurrently -Strong interpersonal and leadership skills, particularly across functions -Solid understanding of medical device manufacturing and regulations (ISO 13485, ISO 9001, FDA QSR) -Strong analytical skills; technical and conceptual attitude - Fluid English Level -Strong computer-based abilities -Position requires work in both office and manufacturing environment -Standing, sitting, walking, reaching with hands and arms to perform keyboard entry, manipulation of computer accessories, inspection of tools / controls -Reach with hands and arms, talking and hearing -Employee will occasionally lift and/or move product, tools, etc. Must have: - VISA (B1 B2 for USA) and Passport to Travel Desirable: Experience within a medical device or hearing aid manufacturing site is a strong plus. -Experience with Customer Complaint Handling. -Knowledge of statistics and analytical problem-solving tools is a strong plus -Electronics, acoustics, and / or industrial engineering knowledge is a plus SAP (or other ERP system) experience preferred
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
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