Sr Assoc - QA QMS

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.

• Ensure the implementation and maintenance of Quality Management System elements at the site.
• Achieve compliance with global quality metrics and submit quality metrics data to the QA Head and management on time.
• Track and implement improvement objectives identified during quality metrics presentations.
• Evaluate departmental efficiency and ensure required training for cross-functional team members is provided.
• Assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules to handle QMS elements effectively across the plants.
• Ensure non-conformities (NCR/SNCRs) are adequately investigated, root causes identified, and effective Corrective and Preventive Actions (CAPA) are implemented.
• Review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions.
• Ensure Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR) are adequately investigated.
• Review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures.
• Monitor and ensure key performance indicators are maintained periodically and achieved.
• Ensure data reliability is in place.
• Conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time.
• Attend CAPA review board meetings and monthly quality metrics review meetings on time.
• Support external and internal audits at the site, providing observations related to QMS compliance.
• Communicate cross-functional requirements to concerned personnel and functions.
• Maintain and monitor the functional budget periodically.
• Support quality functions as required by the business.
• Inform key management teammates about critical quality-impacting QMS elements and raise concerns about potential deviations that could affect quality metrics.

Join us at Baxter Healthcare Corporation, where your expertise and ambition will help us compete globally and deliver outstanding healthcare solutions. Apply today and become a vital part of our mission to achieve flawless quality and compliance.

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

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