Quality Assurance System Manager

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.

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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.

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