3 publicaciones de empleo destacadas de supplier quality engineer en baja california (¡Están contratando!)

QA/RA Lead
Amphenol CMT - Critical Medical Technologies —Tijuana, B.C.
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Excel
- Administración de personal
- Seguro de gastos médicos
- Seguro de vida
Quality Manager H/F
Amphenol TCS de México S.A. de C.V —Mexicali, B.C.
- Administración de personal
- Ensamblaje
- Licenciatura
Postulación rápida
Gerente de Calidad
The Fi Company —Tijuana, B.C.
- Tiempo completo
- Administración de personal
- ERP systems
- Inglés
13d

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QA/RA Lead

Amphenol CMT - Critical Medical Technologies
Tijuana, B.C.

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Información del empleo

Tiempo completo

Beneficios

Seguro de gastos médicos
Seguro de vida

Cualificaciones

Microsoft Powerpoint
Software estadístico
Microsoft Excel
Administración de personal
Six Sigma Green Belt
Inglés
Minitab
Licenciatura
Análisis de riesgo
Experiencia en manufactura
Liderazgo

Descripción completa del empleo

Descripción y detalle de las actividades

Develop and coordinate regulatory plans with full implementation of new and modified products.
Surveillance of the compliance of the Quality Management System.
Suggests and implements measures to improve QMS performance.
Coordinate regulatory research to support regulatory submissions and regulatory advice.
Coordinate and prepare regulatory information, technical Files and others (as applicable) to compliant within the national regulation.
Review engineering changes (as applicable) to support regulatory compliance.
File, update, and maintain regulatory submissions in accordance with current US and foreign regulations for facility registrations,certifications, and licenses.
Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
Develop, implement, and maintain the Quality Management System that apply to the activities that occur to be following international regulation.
Manage Document Control area and assign task and responsibilities including but not limited to resources and priorities.
Manage and coordinate internal, external and supplier audits to follow national and international regulation.
Participate in the performance of the environmental management system in accordance with current roles and responsibilities.
Audit our systems based on standards requirements.
Manages and supervises quality control and training reports for proper follow-up.
Set and track quality assurance goals.
Coordinate with internal / external quality assurance auditors to ensure legal compliance.
Work with internal teams to increase customer satisfaction by improving the quality of the products.
Support to all programs and initiatives in the areas of Hygiene, Safety, Environmental and Quality.
Support for all programs and initiatives related to company's Internal Labor and securities regulations.

Experiencia y requisitos

Quality Assurance & Regulatory Affairs ensure that the company adheres to all applicable laws and regulations, including health and safety, environmental and customer requirements, manage and coordinate internal and external and supplier audits to be in compliance with national, international (if applicable) and internal regulations, ensures the correct implementation of Quality Management System, which includes supervises and coordinates the quality resources as required on the different QA/RA areas, ensuring that the processes and product are following the specifications and standards stablished by customer and the organization.

Bachelor’s Degree in Engineering (industrial, chemical, mechanical, or related).

Ideal to have 3-5 years of experience in medical device manufacturing processes.
ISO 13485 certified internal auditor.
Knowledge QSR/JPAL/CE Mark requirements
Risk Management analysis.
Advance Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases.Etc.).
Ideal to have advanced training skills.
Knowledge of National and International Medical Manufacturing Quality Standards.
Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related.)
Knowledge of ISO 14001 Environmental management System
Leadership skills.

Beneficios

Beneficios de acuerdo a la LFT
Seguro de vida
Seguro de gastos médicos
Servicios medicos en planta
Comedor
seguro de vida
comedor

Número de vacantes 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No

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supplier quality engineer empleos en baja california

QA/RA Lead

Quality Manager H/F

Gerente de Calidad

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