Spec, Quality
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.
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Apoyo a las padres
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Educación continua/ Desarrollo profesional
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Salud de los empleados y Beneficios de bienestar
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Tiempo libre pagado
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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
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.
Dirección
Col. Cañon del Padre
22203 Tijuana, BCN
Mexico Explorar esta ubicación
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