Senior Quality Engineer: Post-Market & CAPA Lead

Milwaukee Succeeds; Round Lake (IL); Hybrid; USD 96,000 - 132,000; Full time

Job summary

Baxter seeks a Senior Engineer, Quality to join our Infusion Therapies and Platforms business in Round Lake, IL. This role supports solution and container design activities within our Design Quality team and helps strengthen product quality across Baxter's therapeutic products and related manufacturing processes.

You will lead post-market risk assessments, drive investigations, and participate in cross-functional CAPA and Change Control reviews, while supporting audits, regulatory compliance,

Qualifications

• BS in Engineering or Science required.
• 3–5 years in Quality or Engineering.
• Experience with quality systems/ISO requirements.

Responsibilities

• Lead post market risk assessments to determine actions.
• Lead product performance investigations via failure analysis.
• Lead or participate in cross-functional Complaint, Change Control and CAPA Reviews.
• Support readiness for audits and inspections.
• Provide Quality support to R&D and laboratory studies and instrument qualification activities.
• Function as Quality Core Team member supporting new/improved product design and implementation projects.
• Define scope of quality deliverables for NPD and SPO development activities.

Skills

Quality processes

Regulatory compliance

Cross-functional teamwork

Problem solving

Education

BS in Engineering or Science

Job description

Baxter seeks a Senior Engineer, Quality to join our Infusion Therapies and Platforms business in Round Lake, IL. This role supports solution and container design activities within our Design Quality team and helps strengthen product quality across Baxter's therapeutic products and related manufacturing processes.

You will lead post-market risk assessments, drive investigations, and participate in cross-functional CAPA and Change Control reviews, while supporting audits, regulatory compliance,