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Quality Engineer
North American Production Sharing de México, S.A. de C.V.
Tijuana, Baja California
Hace 20 horas
Corporativo
Giro
Maquiladora (Export.)
Actividad principal
Administración de maquiladoras.
Número de empleados
10000
Sitio Web corporativo
Descripción y detalle de las actividades
QA Production Engineer
Job Functions
- Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA.
- Responsible for reviewing, approving, and releasing functional reports performed.
- Manage database of the released lots and the components used on each lot to ensure traceability.
- Reconciliation of released finished product and SCRAP quantities.
- Ensure produced quantity of final product is aligned with customer work orders.
- Transfer of DHR's using the electronic platform designated by customer.
- Assign lot numbers for different manufacturing processes.
- Oversee activities of QA production crew.
- Assist in the coordination of QA resources for the different manufacturing processes and overtime needs.
- Manage Supplier Control program and maintain ASL.
- Generate Quality Agreements and Supplier Surveys.
- Conduct Supplier Audits and generate reports.
- Evaluate Manufacturing Deviations and support resolutions.
- Conduct Internal audits and generate audit reports.
- Assign, capture, and control equipment and process validation numbers as required by engineering.
- Responsible for generating, maintaining, and controlling Asset Numbers, and facility Inventory Numbers.
- Participates in activities related with the preparation of external audits.
- Act as a SME for QA production processes and Supplier Control during external audits.
- Assist in the creation of reports and charts for the Measurement of KPI's related to the quality department.
- Be an active enforcer of good manufacturing practices inside and outside the quality department.
- Assist in product rework activities, generating forms for the in-process and final release inspections and controls required for quality assurance.
Experiencia y requisitos
Knowledge and Requirements
- Minimum of 5 years of professional experience in Quality Assurance, preferably in regulated industries.
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Advanced English proficiency, with strong written and verbal communication skills.
- Solid knowledge of Quality System Regulations (QSRs) and hands-on experience with ISO 13485:2016 standards.
- Demonstrated ability to apply quality requirements to procedures, documentation, audits, and continuous improvement initiatives.
Location: Parque Industrial El Pacífico
Schedule: Monday to Friday, 7:00 a.m. to 5:00 p.m.
Beneficios
Número de vacantes 1
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
- Tiempo completo
- Lunes a viernes
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No
