Quality Engineer

hace 3 semanas


Tijuana, México TACNA OUTSET A tiempo completo

Review systems and processes to develop continued improvements through data analysis.
- Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
- Analyzes and performs failure analysis (investigations) to non-conforming products.
- Leads in the implementation of assurances, process controls, nonconformances and CAPA.
- Support process validations for manufacturing process. (IQ, OQ or PQ).
- Develops and prepares monthly quality trend analysis and reports.
- Excellent interpersonal skills.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude

Bachelor's degree in engineering or technical field or equivalent experience is required. **Minimum of 5 years of quality experience in a medical device or other regulated industry is required. ** Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. **Able to read and understand technical data (drawings, GD&T, etc) ** Competent using Microsoft Office suites. **Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology. ** Ability to multi-task and manage multiple assignments in a timely manner. **Good communication and interpersonal skills. ** Strong analytical skills. **Sound knowledge of FMEA. ** Green Belt certification or equivalent a plus.

English : 90%

Certifications**:SIX SIGMA, GREEN BELT CERTIFIED 21 CFR PARTE 820 Auditor certificado ISO 13485 GMP’s para Dispositivos Médicos RISK MANAGEMENT ISO 14971**

Skills: - Manejo, Resolucion de conflictos y estrés laboral Elaboración de FMEA ¨s

Tipo de puesto: Tiempo completo

Salario: $1,000.00 - $1,500.00 al día

Horario:

- Diurno

Pregunta(s) de postulación:

- Cual es su nível de Inglés ?
- Cuenta con Visa Vigente?
- ¿Cuántos años de experiência tienes en empresa medica?

Experiência:

- QUALITY ENGINEER: 1 año (Deseable)


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