Senior Quality Associate – QMS & Investigations Lead

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

Benefits offered by this job

Medical and dental coverage

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Commuting benefits

Job summary

Baxter seeks a Quality professional to lead senior-level ownership of QMS processes in the US, driving CAPA, change control, investigations, and regulatory readiness. You will help ensure compliant records and strong data-driven quality metrics across the organization.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Supplier Quality to deliver inspection-ready documentation in eQMS platforms and to drive continuous improvement in quality systems.

Qualifications

• Bachelor's degree in science, engineering, or related discipline.
• 4+ years of experience in Quality Assurance or Quality Systems in regulated environments.
• Experience leading CAPA and change control activities.
• Strong data analysis and dashboarding skills (Power BI, Excel, Tableau).
• Experience with FDA/ISO inspections and regulatory audits.
• Excellent technical writing and cross-functional collaboration.

Responsibilities

• Own or oversee QMS processes including CAPA, change control, complaints, NCRs, metrics.
• Lead complex quality investigations and develop corrective actions.
• Prepare management review materials and executive summaries.
• Ensure inspection readiness and regulatory compliance.
• Maintain inspection-ready records in eQMS platforms.
• Partner with Manufacturing, Regulatory, Supplier Quality, and other functions.
• Support internal and external audits and respond to auditor requests.
• Provide training and coaching on QMS expectations.

Skills

Quality Assurance

QMS

CAPA

Change control

Investigations

Data analysis

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in science/engineering

Tools

TrackWise

Veeva

MasterControl

ETQ

SmartSheet

Power BI

Excel

Tableau

SAP

Job description

Baxter seeks a Quality professional to lead senior-level ownership of QMS processes in the US, driving CAPA, change control, investigations, and regulatory readiness. You will help ensure compliant records and strong data-driven quality metrics across the organization.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Supplier Quality to deliver inspection-ready documentation in eQMS platforms and to drive continuous improvement in quality systems.