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Quality Assurance System Manager

Req # JR - 168562 Location Monterrey, Nuevo León, México Job Category Quality Date posted 05/06/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Quality Assurance System Manager

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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.

About Us: Baxter´s mission

Our products and therapies touch the lives of millions of people around the world every day, which is why we are passionate about ground-breaking innovations that brings more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.

Your Team

We develop quality products with the patient in mind, so our efforts are also patient-centric. That means you can be proud of our work and the value we provide to people every day.

As a large, multinational organization, you have the opportunity to expand your knowledge through collaboration with a variety of individuals, exposure to different facets of our portfolio, and a supportive leadership team that encourages ongoing development.

This is where you save and sustain lives!!

Your role at Baxter

Demonstrate leadership in support of Baxter values, mission, and objectives. Ensure compliance with United States, Mexico, and International regulatory requirements, as well as internal policies and procedures. Provide leadership in collaboration to analyze and respond to any quality and regulatory issues. Act as the main contact with regulatory agencies for the site.

What you'll be doing!

  • Lead and collaborate with global business partners to ensure Global QMS compliance with regulatory standards.

  • Provide strategic leadership for the implementation and ongoing development of an effective Global QMS.

  • Consult and collaborate with Global Business Process owners to interpret, construct, and apply robust processes into the Global QMS.

  • Proactively review, analyze, and implement opportunities for continual improvement of the Global QMS to meet business needs.

  • Establish and maintain metrics and feedback mechanisms to monitor the continued efficiency of the systems to business and regulatory needs. Interpret and implement associated action plans and ensure effective communication to collaborators.

  • Often must lead a coordinated effort among members of a project team.

  • Mentor team members on performance and provide inputs for performance evaluations and development.

  • Act as the main contact for external quality and regulatory agencies.

  • Define the strategy for Audit readiness for the site.

  • Coordinate the CAPA process for the site.

  • Assist as needed with corporate Quality Systems initiatives.

  • Manage computer system approvals and individual rights and access as required.

  • Lead the Quality Management System.

  • Define and train internal auditors.

  • Lead the CAPA process.

  • Handle the logistics quality system through a third party.

  • Maintain and improve the document system.

What you'll bring

  • Professional in Engineering or other fields; a Master’s degree is desirable.

  • 5 to 7 years of experience in Quality Assurance or Regulatory Affairs, with medical device experience.

  • Knowledge of medical devices or other industries regulated by the FDA.

  • Knowledge of ISO Quality System Standards (preferably ISO9001 and/or ISO13485).

  • Proficiency in computer programs (Excel, Word, PowerPoint, etc.).

  • Advanced English (verbal/written).

  • USA VISA.

#LI-AC1

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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Address

Explore this location Ave. del Teléfono #200
Huinalá en Apodaca
66640 Monterrey, NLE
Mexico Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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