Quality Systems Supervisor

hace 2 semanas

Tecate, México Emprego MX A tiempo completo

Descripción y detalle de las actividades

Responsible for operating the Quality Management System (QMS) and writing procedures to support the QMS development. Responsible for administering the Internal Audits, CAPA, Calibration, Nonconformance, Customer Complaints, and Document Control areas. Provide responses and documentation to external agencies and regulatory bodies. 1. Supervise the effective implementation of the Quality Management System throughout the facility. 2. Maintain the Quality Procedures and ensure contents are appropriate. 3. Analyze current and future procedural needs. 4. Coordinate the Internal Quality Systems Audits Process and assist in training/guidance to other auditors 5. Coordinate, Preparation and Host External Quality System audits. 6. Supervise the activities for CAPA system, Nonconformance Process, Calibration Process, Customer Complaints Process, and Document Control Process. 7. Coordinate, Generate and Present the Quality Systems Metrics (Scorecard’s) 8. Coordinate and provide the quality system documentation required by the Corporate Regulatory Department for the registration of the products in other countries 9. Coordinate, Generate and Host the Management Review 10. Coordinate, Generate, and Host the monthly Quality Data Metric Review 11. Report the state of the Quality Management System to the site Management Representative 12. Perform root cause analysis to resolve problems 13. This function can assist as a Lead Internal Auditor 14. This position is the SME for this function and can provide training for the listed responsibilities 15. Perform any other related task that is assigned by the supervisor.

Experiência y requisitos
- Bachelor’s degree on engineering or equivalent. - Advanced English (Reading and Writing that allow fluid Presentations and /or Participation in Negotiation Processes). - ISO 13485 Lead Auditor. - 5 years of experience on a Medical Device Industry on the Quality Area working experience for ISO 13485, QSR (21 CFR Part 820).

Organización

Teleflex

Giro

Maquiladora (Export.)

Actividad principal

Manufactura de dispositivos medicos diversos.

Número de empleados

750

**Área** Calidad

**Contrato** Permanente

**Turno** Mixto

**Jornada** Tiempo Completo

**Horario** Lunes a Jueves de 7-5:30pm / Viernes de 7-1pm

**Estudios** Carrera Profesional

**Inglés **Hablado: 85%, Escrito: 85%

**Sexo** Indistinto

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