Lead Quality Investigator – CAPA & Deviations

Baxter International; Round Lake (IL); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter International is seeking a Quality Investigation Lead in Round Lake, IL. You will independently manage investigations from initiation to completion, applying structured problem-solving and evidence-based conclusions to support corrective actions and patient safety.

You will collaborate with cross-functional teams to assess impact, develop CAPAs, and ensure records are inspection-ready. The role emphasizes technical writing, data analysis, and adherence to regulatory quality systems.

Qualifications

• Bachelor's degree or equivalent in a technical discipline in a regulated industry.
• 3+ years in pharmaceutical/biotech/medical device/manufacturing/regulatory quality.
• 2+ years leading investigations, deviations, or CAPAs.

Responsibilities

• Lead quality investigations for deviations, nonconformances, complaints, and other quality events.
• Analyze manufacturing, laboratory, engineering, and quality-system data to identify facts and evaluate evidence.
• Develop hypotheses and determine root causes using structured problem-solving methods.
• Assess impact to products, processes, data, and patients; support risk-based decisions and disposition.
• Collaborate with cross-functional experts to gather evidence and drive alignment.
• Recommend CAPAs to address causes and reduce risk.
• Create clear, inspection-ready investigation reports in the eQMS.

Skills

Root cause analysis

Risk assessment

Cross-functional collaboration

Analytical thinking

Technical writing

Project management

Facilitation

Education

Bachelor's degree in Science/Engineering/Pharmacy/Life Sciences/Quality

Tools

TrackWise

eQMS

Job description

Baxter International is seeking a Quality Investigation Lead in Round Lake, IL. You will independently manage investigations from initiation to completion, applying structured problem-solving and evidence-based conclusions to support corrective actions and patient safety.

You will collaborate with cross-functional teams to assess impact, develop CAPAs, and ensure records are inspection-ready. The role emphasizes technical writing, data analysis, and adherence to regulatory quality systems.