Senior Quality Engineer – Medical Devices & Compliance

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

Benefits offered by this job

Medical benefits

Dental benefits

401(k) with company match

Employee stock purchase plan

Paid time off

Job summary

Baxter in Round Lake, IL is seeking a Senior Engineer, Quality to join our Infusion Therapies and Platforms business. You will support product life cycle activities and improve product quality across Baxter’s therapeutic products, including manufacturing and quality processes.

This role collaborates with R&D, QA, and operations, leading risk assessments, investigations, and cross-functional review boards. A BS in engineering or science plus 3–5 years in quality is required; Master’s degree can

Qualifications

• BS in Engineering or Science with a minimum of 3–5 years in Quality or Engineering.
• Master’s degree can substitute for 2 years of experience.
• Experience with quality systems and ISO requirements.
• Working in a regulated manufacturing environment is preferred.

Responsibilities

• Leads Post Market Risk Assessments of product issues to assess the need for Action
• Leads product performance investigations via failure analysis
• Leads or participates in cross functional Complaint, Change Control and CAPA Review Boards
• Supports cross functional teams in audits and inspections readiness
• Provides Quality support to R&D and laboratory studies, investigations, and instrument qualification
• Functions as Quality Core Team member supporting new and improved product design and implementation projects
• Defines scope of quality deliverables and support for NPD and SPO development activities

Skills

Quality concepts

Regulatory awareness

Cross-functional teamwork

Problem solving

Education

BS in Engineering or Science

Master's degree allowed in lieu

Job description

Baxter in Round Lake, IL is seeking a Senior Engineer, Quality to join our Infusion Therapies and Platforms business. You will support product life cycle activities and improve product quality across Baxter’s therapeutic products, including manufacturing and quality processes.

This role collaborates with R&D, QA, and operations, leading risk assessments, investigations, and cross-functional review boards. A BS in engineering or science plus 3–5 years in quality is required; Master’s degree can