Senior Quality Engineer, Product Integrity & CAPA

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

Benefits offered by this job

Health insurance

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off

Job summary

Baxter in Round Lake, IL seeks a Senior Engineer, Quality to join the Infusion Therapies and Platforms business. This role supports design quality, product lifecycle activities, and improvements across a range of Baxter's therapeutic products.

You will lead investigations, CAPA reviews, and audits readiness, collaborating with R&D and manufacturing. A BS in engineering or science with 3–5 years experience, plus ISO experience, is required.

Qualifications

• BS in Engineering or Science with 3–5 years in Quality or Engineering.
• Master's degree can substitute for 2 years of related experience.
• Experience with quality systems/ISO requirements in a regulated manufacturing environment.
• Strong ability to engage cross-functional teams and influence decisions.

Responsibilities

• Lead Post Market Risk Assessments of product issues to assess the need for Action.
• Lead product performance investigations via failure analysis in complaints or trends.
• Lead or participate in cross functional Complaint, Change Control and CAPA Review Boards.
• Support readiness for internal and external 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.

Job description

Baxter in Round Lake, IL seeks a Senior Engineer, Quality to join the Infusion Therapies and Platforms business. This role supports design quality, product lifecycle activities, and improvements across a range of Baxter's therapeutic products.

You will lead investigations, CAPA reviews, and audits readiness, collaborating with R&D and manufacturing. A BS in engineering or science with 3–5 years experience, plus ISO experience, is required.