QA Systems Engineer - Onsite Weekdays Job Town of Ridgeway New York USA,Engineering

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.

Your role at Baxter

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

Important:
This position is located in Medina, NY and is designed as an onsite role, with an encouraged presence of five (5) days per week to foster collaboration, innovation, and connection across the team. Baxter is seeking candidates who reside within a reasonable commuting distance and are able to regularly support the business through in-person engagement and partnership at the Medina site.

What You'll Be Doing

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

What You'll Bring

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.

PHYSICAL DEMANDS

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…