Senior Quality Engineer – Post-Market & CAPA Lead

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

Benefits offered by this job

Medical & dental

401(k) with match

ESPP

Educational assistance

Paid time off

Job summary

Baxter International Inc. seeks a Senior Engineer, Quality in Round Lake, IL to advance design quality and product lifecycle management across therapy platforms.

You will lead post-market risk assessments, investigations, and cross-functional CAPA reviews while supporting audits, R&D QA activities, and qualification programs. Required BS in Engineering or Science with 3–5 years in Quality or Engineering; Master’s can substitute for 2 years.

Qualifications

• BS in Engineering or Science with 3–5 years in Quality or Engineering.
• MS degree can substitute for 2 years of experience.
• Experience with quality systems and ISO requirements.

Responsibilities

• Lead post-market risk assessments and action decisions.
• Conduct product performance investigations and trend evaluations.
• Support cross-functional Complaint, Change Control and CAPA Boards.
• Assist audits and inspections readiness across teams.
• Provide QA support to R&D, labs, investigations, and instrument qualification.
• Define scope of QA deliverables for NPD/SPO development.

Skills

Quality systems / ISO

Cross-functional collaboration

Problem solving

Regulatory compliance

Root cause analysis

Documentation

Education

BS in Engineering or Science

Master’s degree acceptable substitute

Job description

Baxter International Inc. seeks a Senior Engineer, Quality in Round Lake, IL to advance design quality and product lifecycle management across therapy platforms.

You will lead post-market risk assessments, investigations, and cross-functional CAPA reviews while supporting audits, R&D QA activities, and qualification programs. Required BS in Engineering or Science with 3–5 years in Quality or Engineering; Master’s can substitute for 2 years.