Quality Associate III

This is where

Your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives.

Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

As a Quality Associate III, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. You will provide senior-level individual contributor ownership and oversight of Quality Management System processes including change control, CAPA, complaints, nonconformance records, and metrics, serving as site SME to ensure inspection readiness and regulatory compliance.

Will also lead complex quality investigations, prepares management review materials, and partners cross-functionally to drive timely resolution of quality system issues while maintaining inspection-ready records in eQMS platforms.

• Own or provide senior-level oversight for assigned Quality Management System processes, which may include change control, CAPA, customer complaints, nonconformance records, metrics, management review inputs, and related eQMS workflows.
• Serve as site SME for assigned QMS processes, including workflow routing, impact assessment, implementation planning, completion tracking, closure quality, and inspection readiness.
• Lead or support complex quality investigations, including complaint investigations, nonconformance evaluations, root cause analysis, corrective/preventive action development, and effectiveness verification.
• Assess proposed product, process, equipment, supplier, documentation, and quality system changes for regulatory, product quality, patient safety, data integrity, and business continuity impact.
• Prepare, analyze, and report QMS metrics, including CAPA timeliness/effectiveness, complaint closure, aging records, change control execution, overdue actions, and adverse trends.
• Develop management review-ready data packages, dashboards, trend reports, and executive summaries that clearly communicate QMS performance, risks, escalations, and recommended actions.
• Partner cross-functionally with Manufacturing, Engineering, QC, Regulatory Affairs, Supplier Quality, Document Control, Medical/Clinical, and site leadership to drive timely and compliant resolution of quality system issues.
• Support internal audits, corporate audits, customer audits, and regulatory inspections by preparing records, explaining process execution, supporting back-room/front-room activities, and responding to auditor requests.
• Identify recurring QMS execution issues and lead continuous improvement initiatives to simplify workflows, improve right-first-time documentation, reduce cycle time, and strengthen compliance.
• Provide coaching, training, and practical guidance to process users, record owners, CAPA owners, change owners, and cross-functional SMEs on QMS expectations and documentation quality.
• Maintain inspection-ready records in Baxter's eQMS platforms.
• Raise significant quality issues, overdue commitments, adverse trends, or potential compliance risks through established site and corporate quality governance processes.

• Bachelor's degree in science, engineering, pharmacy, life sciences, quality, regulatory affairs, or a related technical discipline.
• 4 plus years of experience in Quality Assurance, Quality Systems, Quality Engineering, Product Surveillance, Manufacturing Quality, or Compliance in a…