Quality Assurance Technical Services Engineer (m/w/d)
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
Quality Assurance Technical Services Engineer (m/w/d)
Vantive: A New Company Built on Our Legacy
Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.
Your role at Baxter
In this role you will ensure that processes and procedures for Technical Services Operations are in compliance with regulatory requirements in Germany, Austria and Switzerland. You will actively participate in the design, implementation and/or maintenance of the quality processes in the field operations.
This role is based in Unterschleißheim near Munich (hybrid option)
What you'll be doing
Quality support to Field Service operation activities in Germany, Austria and Switzerland
Local process ownership for the Technical Services Quality Systems: documentation, procedures, training, internal and external audit, CAPA and non-conformities, compliance to post marketing surveillance activities (product complaints, medical device vigilance, and Field Corrective Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process and risk assessment
Support and ensure compliance with field operations processes: device release, labelling, storage areas, calibration, decontamination, equipment validations and repair
Maintain a strong relationship with the local Technical Services team
Local Auditor and Local Trainer
Quality KPIs- trending and actions
Support or lead local and/or European projects
What you'll bring
Master’s degree in electrical/electronic engineering or equivalent degree in the technical/technology field
Minimum 1-3 years of experience in quality management in a medical device or technical service organization – quality processes related to service activity OR experience in technical service/ manufacturing environment
Quality System and Quality Assurance knowledge in operations
knowledge of ISO 9001:2015 and ISO 13485:2016
Expertise in medical device or electro-mechanical products
Ability to manage different tasks in an international environment
Effective interpersonal skills
Excellent written and oral communication skills in English and German. A third language e.g. Spanish, French or Italian is a plus
Ability & Willingness to travel
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
Have we sparked your interest?
If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.
#IND-DACH
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
85716 Munich
Germany Explorar esta ubicación
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