Senior Quality Systems Specialist

Baxter International Inc.; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Job summary

Baxter is seeking a Quality Associate III to own and oversee key Quality Management System processes, including change control, CAPA, complaints and metrics. You will act as site SME to ensure inspection readiness and drive timely resolutions across cross-functional teams.

The role involves leading complex investigations, preparing management materials, and building dashboards to monitor QMS performance while upholding Baxter’s commitment to quality.

Qualifications

• Bachelor’s degree in science, engineering, pharmacy, life sciences, quality, regulatory affairs, or related discipline.
• Hands-on experience with QMS elements: change control, CAPA, complaints, NCR, deviations, audits, and metrics.
• Experience supporting FDA/ISO inspections and cross-functional collaboration.

Responsibilities

• Own or oversee Quality Management System processes (change control, CAPA, complaints, NCR, metrics).
• Serve as site SME for QMS processes, ensuring inspection readiness.
• Lead complex quality investigations and prepare management review materials.
• Develop data packages, dashboards, and executive summaries on QMS performance.

Skills

Quality Assurance

Quality Systems

CAPA

Change Control

Investigations

Data Analysis

Cross-functional Collaboration

Dashboards

Education

Bachelor's degree in science/engineering/pharma

Tools

Excel

Power BI

Tableau

SmartSheet

eQMS tools

TrackWise

Veeva

MasterControl

Job description

Baxter is seeking a Quality Associate III to own and oversee key Quality Management System processes, including change control, CAPA, complaints and metrics. You will act as site SME to ensure inspection readiness and drive timely resolutions across cross-functional teams.

The role involves leading complex investigations, preparing management materials, and building dashboards to monitor QMS performance while upholding Baxter’s commitment to quality.