Tijuana, Baja California- Beneficios de acuerdo a la LFT
- Seguro de vida
- Seguro de gastos médicos
Corporativo
Giro
Maquiladora (Export.)
Actividad principal
Manufactura de productos médicos.
Número de empleados
3000
Sitio Web corporativo
Descripción y detalle de las actividades
- Manage the human and material resources assigned to the department.
- Ensure production processes comply with established quality standards.
- Review and follow up on quality nonconformances.
- Implement engineering changes and deviations as required.
- Coordinate product rework activities.
- Design production fixtures.
- Develop production area layouts.
- Determine product sterilization cycles.
- Define staffing requirements for each production line.
- Develop production process flow diagrams.
- Create and maintain Bills of Materials (BOMs).
- Update and revise manufacturing procedures.
- Perform product design verification and validation testing, as required.
- Develop visual work instructions and production aids.
- Conduct time studies and line balancing analyses.
- Participate in the validation of new production lines.
- Apply knowledge of quality standards, policies, and procedures, including ISO 13485 and FDA regulations.
- Utilize continuous improvement methodologies and tools.
- Implement quality improvements in production processes.
- Support and monitor product transfer activities.
- Manage and follow up on raw material rejections.
- Support internal and external quality audits.
- Analyze internal product rejections related to nonconformances.
- Generate process deviations when required.
- Follow up on audit findings and nonconformances.
- Verify critical quality control points throughout the manufacturing process.
- Request equipment repairs as necessary.
- Provide general supervision of the assigned area, ensuring cleanliness, discipline, and adherence to 5S principles.
- Understand and comply with policies and procedures related to the Quality Management System (ISO 13485), Environmental Management System (ISO 14001), Occupational Health and Safety Management System (OHSAS 18001), and any other management systems required for company operations.
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.
*This position is temporary (20M)
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