Senior Quality Engineer
hace 5 meses
**Technimark** Empresa Líder a Nível Mundial de Inyección de Plásticos busca Candidatos para el puesto de
**Ingeniero Calidad Senior **en su planta ubicada en
**Mexicali, Baja California.**
Reporta a:
**Gerente de Calidad.**
Supervisa a:
** Inspectores de Calidad.**
**Experiência Requerida**:
- 3 Años en Posición Similar.
- 5 Años como supervisor de calidad, Coordinador de Sistemas de gestión
**Nível de Formación**:
- Carrera Universitaria Concluida.
**Ingles**:
- C-1 Fluido Marco Común Europeo.
**Conocimientos Indispensables**:
- ISO 9001.
- ISO 13485
- Core Tools (PPAP, SPC, APQP, Control Plan, MSA, FMEA)
- Análisis y Solución de Problemas (CQI-20 / 8D).
- Metrología.
- GD&T.
- Software estadístico (MiniTab, JMP o similar)
- Process Validations for Medical Devices (IQ, OP, PQ) & NPI.
- Controles para Cuarto Limpio
- Microsoft office
**Conocimientos Deseables**:
- 14001, IATF 16949.
- Conocimiento Moldeo por Inyección.
- Auditor Interno en ISO 9001 y/o ISO 13485 / 21 CFR 820.
- HACCP o BPM (Buenas Prácticas de Manufactura)
- Lean Manufacturing.
- Instructor Interno.
- Six Sigma - Green Belt.
- CQE -Ingeniero de calidad certificado por ASQ.
- Medical Device Directive to Medical Device Regulation (MDR)
- Risk Management for Medical Devices ISO 14971
- Cleanrooms and controlled environments - ISO 14644-1
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