Senior Quality Engineer, Medical Devices & Compliance

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

Job summary

Baxter is seeking a Senior Engineer, Quality to join our Infusion Therapies and Platforms team in Round Lake, IL. You will support product life cycle activities, quality processes, and design quality initiatives across a broad range of Baxter therapies.

The role emphasizes cross-functional collaboration, support for R&D and investigations, and leading risk assessments and CAPA boards to improve product quality. Strong ISO knowledge and regulatory experience are essential.

Qualifications

• BS in Engineering or Science with 3–5 years of related experience.
• Master’s degree can substitute for 2 years of experience.
• Experience with quality systems/ISO requirements.

Responsibilities

• Lead post market risk assessments to evaluate actions.
• Lead product performance investigations and trend analysis.
• Participate in cross-functional complaint, change control and CAPA boards.
• Support audits and inspections readiness.
• Provide quality support to R&D, labs and instrument qualification.
• Contribute to design quality in new product development projects and manage complex issues.
• Define scope of quality deliverables for NPD and SPO.

Skills

Interdisciplinary understanding

Stakeholder influence

Cross-functional teamwork

Business-aware problem solving

Problem solving under ambiguity

ISO quality standards

Regulatory compliance

Education

BS in Engineering or Science

Master’s degree substitute 2 years experience

Job description

Baxter is seeking a Senior Engineer, Quality to join our Infusion Therapies and Platforms team in Round Lake, IL. You will support product life cycle activities, quality processes, and design quality initiatives across a broad range of Baxter therapies.

The role emphasizes cross-functional collaboration, support for R&D and investigations, and leading risk assessments and CAPA boards to improve product quality. Strong ISO knowledge and regulatory experience are essential.