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Hybrid Quality Analyst

BAXTER · Cali, Valle del Cauca, Colombia · Hybrid

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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.

Join us now!

Your role at Baxter

Responsible for implementing and maintaining the quality system within Latin America – Global Technical Services. This includes reviewing documents, releasing devices and spare parts, developing SOP’s and coordinating holds.

What you'll be doing

  • Monitor compliance and support implementation of Global and local policies, procedures, and regulations. Knowledge and maintenance of current and pertinent standards (as applicable to countries under responsibility – Latin America North (LAN) / Latin America South (LAS).

  • Support activities across the Latin America region as needed. Adheres to all environmental, health and safety SOP’s.

  • Perform quality training to new employees. Feed Quality indicators as needed to facilitate quality reviews. Act upon results to drive improvement.

  • Initiate as needed non-conformances, lead and/or own investigations to identify root causes, and monitor or execute actions to ensure timelines are met. Also, lead investigation of NCR’s and audit observations cited to the facility to identify root causes and monitor or execute actions to ensure timelines are met.

  • Review through sampling plan documental evidence of medical device services approved by field service and depot service engineers and feed results to quality indicator such as First Pass Yield (FPY) or to other quality systems like CAPA.

  • Complete QA SOPs gap assessments perform or review translations; update SOPs as required and monitoring actions for proper implementation.

  • Assist External, Internal and Corporate audits by preparing in conjunction with operations pre-audit information, attending audits, and providing evidence.

  • Perform release and approval of spare parts following local requirements and using approved systems (JDE).

  • Support all other QA System elements such as FCA, Complaints, Holds, Change Controls, Supplier Quality and Validations.

What you'll bring

Bachelor of Biomedical Engineer, Science or related.

3-5 years of Quality Experience within medical device or other regulated industry.

Advance level of English.

Be part of our mission to save and sustain lives.

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.

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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.