![](https://tbcdn.talentbrew.com/company/152/v4_0/img/ajd-hero-quality-sm.webp)
Sr Executive, Product Surveillance
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
Sr Executive, Product Surveillance
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B 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 separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Summary:
Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Associate will be responsible for evaluating potential product quality complaints, initiating timely actions in association with coordinating the investigation to complaint closure. Ensure applicable, local, national and international regulatory requirements and internal expectations are met.
Essential Duties and Responsibilities:
- Evaluate potential product quality complaints and initiate applicable records & actions within proper Quality System.
- Own and process quality complaint as per applicable procedures.
- Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures.
- Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required.
- Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure.
- Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints.
- Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization.
- Implement and maintain Post Market Surveillance documents (PMSP, PSUR, etc.) as per EU Medical Device Regulation.
- Performs other duties as needed and assigned.
Qualifications:
- Excellent verbal and written communication skills.
- Analytical approach to problem solving.
- Ability to handle and manage workload independently
- Well organized and able to multitask effectively in a rapid paced environment, as well as show assertiveness, when interfacing with other personnel during the complaint handling process.
- Experience with Trackwise or equivalent complaint tracking system software and Microsoft Office and database skills are required.
- Knowledge of FDA/ ISO regulations and Country requirements.
- Knowledge of MDR and MDV reporting.
Education and/or Experience:
- Bachelor’s Degree – Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.).
- Prior experience (2+ years) with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory.
- Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred).
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
![](http://tbcdn.talentbrew.com/company/152/v4_0/img/icon-location-pin.png)
Gurgaon- 122002
Haryana
India Explorar esta ubicación
Contenidos relacionado
-
March 05, 2024
-
Beneficios para los empleados Nuestras amplias opciones de prestaciones reflejan el valor que otorgamos a nuestros empleados. March 28, 2024
-
Gente de Baxter La gente de Baxter son hombres y mujeres que marcan la diferencia en el trabajo y en sus comunidades. March 28, 2024
-
March 05, 2024
-
March 05, 2024
-
Cómo postularse Aprende consejos para prepararte mejor para el proceso de postulación. March 05, 2024 Related Content - SR_JD
-
March 05, 2024
-
March 05, 2024
-
Our Proposed Separation We plan to separate our Kidney Care Global Business Segment from Baxter to become a separate company. Discover what this means for you. May 03, 2024 Related Content - SR_JD
-
Áreas profesionales Explora nuestras distintas áreas profesionales y descubre el que mejor se adapta a tus talentos y objetivos profesionales. March 05, 2024 Related Content - SR_JD
Únete a nuestra comunidad de talentos
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.