Ingeniero Calidad
On-siteGać, Subcarpathia, Poland
Job Summary
Coordinate process validations, manage customer complaints, and oversee non-conformance processes for the Mexicali sites to ensure compliance with established procedures. Investigate errors from Bag & Box and Final Inspection areas while maintaining the quality database to track product trends. Lead internal process audits, calibrate measurement equipment, and communicate quality issues to relevant staff. Manage incoming material non-conformities and support the release of validated processes. Requires a degree in engineering, over three years in quality validation, and ISO 13485 certification. Fluency in English and experience in regulated medical manufacturing environments are essential. Availability for rotating shifts and weekends is required.
Required Qualifications
- Licenciatura en Ingeniería
- Más de 3 años de experiencia en validación de procesos y sistemas de calidad
- Inglés intermedio-avanzado
- Certificación o experiencia como Auditor Interno o Auditor Líder en ISO 13485:2016 o estándares similares (ISO 9001)
- Disponibilidad para trabajar en diferentes turnos y fines de semana cuando sea necesario
Desired Qualifications
- Conocimientos en Lean Manufacturing
- Manejo intermedio de Microsoft Office
- Interpretación de dibujos mecánicos
- Experiencia en cuartos limpios y maquinaria de ensamble
- Conocimiento en ambientes regulados de manufactura médica
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.