QA Systems Engineer: Validate, Improve & Drive Quality

Baxter International Inc.; Kentucky; On-site; USD 76,000 - 105,000; Full time

Benefits offered by this job

Health and dental benefits

Employee stock purchase plan (ESPP) &

401(k) retirement plan

Job summary

Baxter International Inc. in the United States is seeking a Quality Assurance Systems Engineer to validate and maintain manufacturing systems in a regulated environment.

You will lead IQ/OQ/PQ/MSA activities, drive change controls, and collaborate with cross-functional teams to ensure product integrity and compliance while supporting process improvements and technical documentation. The role emphasizes data-driven analyses, rigorous adherence to cGMP, and opportunities to influence equipment

Qualifications

• Bachelor’s degree in Engineering with 1–3 years of engineering experience preferred.
• Experience with process improvement methods (e.g., six sigma, lean) preferred.
• Experience developing and deploying Quality Systems in manufacturing/medical device settings.

Responsibilities

• Validate processes and equipment (IQ/OQ/PQ) and generate validation reports.
• Lead or assist change control per procedural requirements.
• Interact with auditors and participate in audits and validations.
• Lead or participate in process improvement projects with minimal guidance.
• Collaborate with cross-functional teams (production, quality, lab).
• Prepare technical reviews, documentation, and data analyses.
• Support design, installation, qualification, and monitoring of processes.
• Provide data-driven analyses and technical reporting.

Skills

Engineering degree or equivalent

Problem-solving

Technical communication

Cross-functional collaboration

CAD knowledge

Validation understanding (IQ/OQ/PQ)

Quality systems

Education

Bachelor’s degree in Engineering

Tools

CAD

Documentation tooling

Job description

Baxter International Inc. in the United States is seeking a Quality Assurance Systems Engineer to validate and maintain manufacturing systems in a regulated environment.

You will lead IQ/OQ/PQ/MSA activities, drive change controls, and collaborate with cross-functional teams to ensure product integrity and compliance while supporting process improvements and technical documentation. The role emphasizes data-driven analyses, rigorous adherence to cGMP, and opportunities to influence equipment