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Spec, Quality

ID de la oferta JR - 151910 Ubicación Tijuana, Estado de Baja California, México Categoría de Trabajo Quality Fecha de publicación 12/13/2024
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Descripción general

Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. Como miembro del equipo de Calidad de Baxter, desempeñará un papel esencial en nuestra misión de salvar y sostener vidas. La calidad es importante durante todo el ciclo de vida del producto y trabaja en colaboración con todas las áreas de la organización. Debido a que Calidad afecta todo lo que hace Baxter, un rol en Calidad brinda muchas oportunidades de crecimiento, aprendizaje y una carrera exitosa que tiene un impacto diario en la vida de las personas.

  • Apoyo a las padres

  • Educación continua/ Desarrollo profesional

  • Salud de los empleados y Beneficios de bienestar

  • Tiempo libre pagado

  • 2 días al año para ser voluntario

Perfil de éxito

¿Qué hace que un miembro del equipo de calidad de Baxter sea exitoso? Revise algunos de los rasgos principales que estamos buscando y vea si su perfil se ajusta.

  • Orientado al detalle
  • Aprendiz continuo
  • Valiente
  • Colaborativo
  • Pensador crítico
  • Influyente

Spec, Quality

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

What you'll be doing

Ensure compliance with  QSR part 820, ISO-13485 and other applicable regulations.

Implements, monitors, improves and reports on metrics to monitor Quality performance.

Ensure that the non-conforming material process is executed in accordance with established procedures and in compliance with determined metrics.

Leads/oversees  validation activities, IQs, TMVs, OQs, PQs, for designated areas

Ensures that the validated status is maintained during any decision-making process.

Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives.

Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness.Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report.

Participates or leads project transfer, through the identification and closing of gaps from the quality system  and manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlinesParticipate in Value Stream projects (quality improvements, cost savings, productivity gains).

Ensure that all inspection and test specifications are properly performed and documented.

Conduct a root cause analysis to prevent recurrence.

Supervise that all personnel reporting to him/her are adequately trained for the functions they perform.

Conducts routinary internal audits, Gembas, LTTs  of the quality system in compliance with procedures. Reports audit results to management.

Supervise and coordinate the function of the Quality Technicians, Quality Intern and Quality Eng C.

Ensures compliance with assigned KPIs and notifies management of any possible impact

Ensures that subordinates' duties and responsibilities are clearly defined and that performance is routinely measured and reviewed. This includes:

  • Definition of performance standards and related objectives;

  • Measurable work standards

  • Evaluating performance to ensure achievement of individual and departmental objectives, using corporate appraisal procedures.

  • Communicate actual performance against the standard to subordinates, reporting results to management.

  • Develop key people to ensure smooth operation.

  • Creates and establishes development plans to build high performing teams

  • Supports analysis, investigation and field actions. Creates consignees list and contacts clients to obtain required information.

  • Creates, monitors and ensures compliance with quality plans.

What you'll bring

  • Excellent verbal and written communication skills (English/Spanish)

  • Bachelor's degree

  • Personnel Management

  • Training - Knowledge on risk management ISO 14971

  • QSR Part 820 Training / Awareness and ISO13485

  • Root cause Analysis

  • Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc. (Deseable)

  • Desired Knowledge  in medical device regulations and standards, including FDA medical device regulations covered by Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC / EU MDR

  • Quality Eng certified by ASQ (Deseable)

  • Green Belt Six Sigma Certified. (Deseable)

  • Five years in similar positions

  • Problem Solving

  • Focused on Results

  • Validation Expirience (IQ, TMVs OQ, PQ,)

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Dirección

Explorar esta ubicación Emilio Flores #2471-A
Col. Cañon del Padre
22203 Tijuana, BCN
Mexico
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Escucha a nuestros empleados

Nuestra empresa se enriquece con una población diversa de personas en más de 100 países que trabajan para resolver, innovar, fabricar e impulsar mejores opciones de atención médica para pacientes de todo el mundo.

Conoce a Christelle, directora sénior de calidad en Malta

“Era una graduada de ingeniería con una maestría en administración de empresas y estaba más inclinada a trabajar con personas que con máquinas. Cuando encontré la oportunidad de trabajar con Baxter como ingeniera de calidad, fue la combinación perfecta: un entorno de fabricación y un rol que me exigía colaborar con múltiples equipos diariamente. La misión de Baxter de salvar y sostener vidas me brinda todo el propósito y la satisfacción que necesito.”

Conoce a Lorena, asociada senior de control de calidad en Londres, Reino Unido

“Soy una farmacéutico registrada en el Reino Unido con experiencia en productos farmacéuticos y en la liberación de productos finales. Soy muy dedicada a mi trabajo y preciso en los detalles para garantizar que se brinde una evaluación correcta a nuestros clientes para garantizar la seguridad de los pacientes.”

Conoce a Gary, director de investigación de calidad en Singapur

“¡Siempre disfruté trabajar en Baxter y considero que este es un excelente lugar para trabajar! La gerencia realmente se preocupa por usted e invierte tiempo y recursos para respaldar sus aspiraciones y objetivos profesionales. Mi puesto actual me brinda la oportunidad de trabajar con personas culturalmente equipos diversos, reuniendo diferentes talentos, aprendiendo unos de otros y trabajando hacia una meta y misión común..”

Ningun recien trabajo ha sido visto

No hay empleos guardados.

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Agradecemos tu interés en una carrera en Baxter y nos gustaría conocerte. Unirte a nuestra Comunidad de talentos es una excelente manera de mantenerse conectado, conocer más a Baxter y ayudar a nuestros reclutadores a encontrarte en caso de que haya una oportunidad que coincida con tu formación, tus habilidades y tus intereses.

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