Descripción y detalle de las actividades
You will be responsible for developing, implementing, maintaining, and measuring the effectiveness of the quality system (inspection systems, policies and procedures, measurement and testing, corrective actions, internal and external audits, etc.) that was established to ensure that the product meets both internal and external quality standards.
**DUTIES AND RESPONSIBILITIES**
Production and distribution product quality matters
For setting Quality KPI's for production and distribution.
For calling and managing TJ production stop in coordination with VP Global Operations Quality.
For ensuring continuous alignment of learning and ways of working across sites.
For compliance with production and distribution standards in Demant, following QMS TJ.
For compliance with quality standards in Demant following QMS- TJ.
For compliance with regulatory standards in Demant Following QMS- TJ.
For creating and maintaining the yearly budget process. (Budget vs Actual balance)
For planning training for quality employees.
For providing input for Management Review according to HIQMS.
CAPA approver and QA Representative.
Validation approver.
For efficient allocation of quality resources, ensuring optimal operational engagement.
Driving the Quality requirements and awareness in Tijuana.
Proactively following the escalation model in case of any adverse events.
Local Quality Management System Representative on behalf of Global Quality
For coordination of activities related to maintaining and improving the quality management system.
For supervision of the corrective and preventive actions.
For preparation and hosting external audit (Customer, Notified Body).
For being compliance with and steer the Internal audit plan.
Experiência y requisitos
The qualifications required for this role are the following:
- Engineering degree
- Work experience in Medical Devices as Quality Manager.
- Demonstrated leadership and supervisory experience.
- Problem solving techniques (5whys, 8Ds, Ishikawa, DMAIC).
- Effective organizational and communications - Fully bilingual (Spanish and English)
- Strong Stakeholder management.
Beneficios
- seguro de vida
- comedor
- fondo de ahorro
- transporte
- uniforme
- gimnasio
- seguro de gastos médicos
- Beneficios de acuerdo a la LFT
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** Si