Tijuana, Baja California- Beneficios de acuerdo a la LFT
- Seguro de vida
- Fondo de ahorro
- Seguro de gastos médicos
- Plan de indexación
- Caja de ahorro
- Comedor
- Transporte
Corporativo
Giro
Maquiladora (Export.)
Actividad principal
Manufactura de productos médicos.
Número de empleados
3000
Sitio Web corporativo
Descripción y detalle de las actividades
- Coordinate and execute validation and revalidation processes (IQ, PC, OQ, and PQ).
- Coordinate and execute opportunity studies; ensure production processes comply with established quality standards and specifications.
- Create and update pFMEAs and pMVPs.
- Implement engineering changes and conduct change evaluations.
- Design fixtures.
- Develop production area layouts.
- Develop production process flow diagrams.
- Knowledge in the creation and maintenance of BOMs and process flow diagrams.
- Create and update manufacturing procedures.
- Perform product design testing.
- Develop visual aids for different production processes.
- Conduct time studies and line balancing.
- Knowledge and application of quality standards, policies, and procedures (ISO 13485, FDA).
- Utilize continuous improvement tools.
- Implement quality improvements in production processes.
- Support and follow up on products undergoing transfer processes.
Experiencia y requisitos
- Bachelor’s Degree in Engineering.
- 1–2 years of experience in the medical manufacturing industry.
- Experience applying root cause analysis and problem-solving techniques.
- Knowledge of Quality Systems (ISO 13485, FDA).
- Experience with validation processes (IQ, process parameter characterization, OQ, and PQ).
- Statistical tools (process capability, DOE, normality analysis, etc.).
- Document generation, including work instructions.
- Participation in or coordination of changes to pFMEA.
- Cleanroom regulations.
- Basic manufacturing knowledge.
- Continuous improvement tools (Lean Manufacturing, Six Sigma).
- Line balancing.
- Time studies.
- Statistics.
- Basic knowledge of electronics, pneumatics, electricity, and PLCs.
- Advanced English proficiency.
*Only candidates who meet all requirements will be considered for an interview.
Beneficios
Número de vacantes 1
Área Ingeniería
Contrato Temporal
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario
- Tiempo completo
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No