QA Systems Engineer

This is where
your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

This document outlines the employment prerequisites and job responsibilities for the Quality Assurance Systems Engineer position.

Reporting to the QA Systems Manager, the primary responsibilities are:

• Support and execute complex validations, including IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems within the facility throughout the validation stages with little or no guidance.

• Own and drive change control based on procedural requirements

• Assist, present, defend, and communicate with external auditors and other validations or projects in which you lead or participated.

• Assist or lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.

• Work collaboratively with a cross-functional team (production, quality, laboratory, etc.)

• Apply solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools and/or specialties such as electrical, mechanical, chemical, industrial, or biological).

• Assists in the preparation and participation of technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.

• Assist management or other engineers during process design, equipment installation, qualification, and/or process monitoring.

• Provide technical reports and/or data-driven analysis after training.

• Other duties as assigned

• Bachelor’s degree in Engineering. 1-3 years of engineering experience preferred.

• Prefer experience and/ or training with process improvement methods (e.g. six sigma, lean)

• Interest in obtaining certifications (ASQ) Experience in the manufacturing and/or medical device industry preferred, including experience in the development and deployment of Quality Systems.

• Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and applying engineering principles.

• Basic understanding of validation guidelines, cGMPs Regulations, and Good Manufacturing Practices, preferred.

• Experienced multitasker with solid prioritization skills is essential

• Support plant initiatives with the development and implementation of new processes/technologies

• Highly motivated to learn and accomplish goals.

• Ability to meet tight deadlines.

• Must be able to sit, stand, or walk throughout the workday.

• Ability to lift and carry up to 20 pounds and perform repetitive hand/finger motions.

• Good hand-eye coordination and dexterity required.

• Dynamic lifting capability: lift 15 pounds floor to shoulder, 2 pounds overhead; push/pull with up to 6 pounds of force.

The work environment is a regulated manufacturing facility governed by FDA and internal quality standards. Employees are expected to comply with all applicable rules and procedures designed to maintain product integrity and safety.

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