Sr. Quality Enigeer
hace 2 semanas
**TECHNIMARK**:
- Empresa LIder a Nível Mundial el Moldeo por Inyeccion busca Candidatos para el puesto de **Ingenierio de Calidad Senior** en la planta de Mexicali.
**Experiência Requerida**:
- Más de 3 años en posición similar.
- Más de 5 años como supervisor de calidad o Coordinador de Sistemas de Gestión.
**Nível de Formación**:
- Carrera Universitaria Concluida.
- Inglés: Nível C-1 Fluido según el Marco Común Europeo.
**Conocimientos Indispensables**:
- Auditor Interno en ISO 9001 y/o 13485.
- 21 CFR 820.
- Herramientas Core (PPAP, SPC, APQP, Plan de Control, MSA, FMEA).
- Análisis y Solución de Problemas (CQI-20 / 8D).
- Metrología.
- GD&T.
- HACCP o BPM.
- Software estadístico (MiniTab, JMP o similar).
- Validaciones de Procesos para Dispositivos Médicos (IQ, OQ, PQ) y NPI.
- Controles para Cuarto Limpio.
- Microsoft Office.
**Conocimientos Deseables**:
- ISO 14001, IATF 16949.
- Conocimientos en Moldeo por Inyección.
- Lean Manufacturing.
- Instructor Interno.
- Six Sigma - Green Belt.
- CQE - Ingeniero de Calidad Certificado por ASQ.
- Directiva de Dispositivos Médicos a Regulación de Dispositivos Médicos (MDR).
- Gestión de Riesgos para Dispositivos Médicos ISO 14971.
- Salas Limpias y Ambientes Controlados - ISO 14644-1.
**Competencias Funcionales**:
- Manejo de Conflictos.
- Liderazgo.
- Negociación.
- Análisis de Problemas.
- Enfoque a Resultados.
- Gestión Colaborativa.
- Toma de Decisiones.
- Trabajo en Equipo.
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