QA Systems Engineer - Onsite Weekdays

Baxter Healthcare; Town of Ridgeway (NY); On-site; USD 76,000 - 105,000; Full time

Benefits offered by this job

Medical and dental coverage starting 1

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter Healthcare in Medina, NY is seeking a QA Systems Engineer responsible for validating processes, equipment, and computer systems including IQ/OQ/PQ and MSAs.

You will support change control, assist with audits, and collaborate with cross-functional teams to drive quality improvements.

Qualifications

• Bachelor's degree in Engineering; 1–3 years engineering experience preferred.
• Experience with validation guidelines (IQ/OQ/PQ) and cGMPs is preferred.
• Experience with process improvement methods (Six Sigma, Lean) desired.
• Strong cross-functional collaboration and technical communication skills.

Responsibilities

• Support and execute complex validations (IQ/OQ/PQ/MSA) for processes, equipment and systems.
• Own and drive change control per procedures.
• Interact with auditors and project teams; present and defend validation efforts.
• Lead or assist process-improvement projects with minimal guidance.
• Collaborate with production, quality, and lab teams for effective outcomes.
• Apply engineering principles and CAD tools to design, scheduling and documentation.

Skills

Cross-functional collaboration

Problem solving

Root cause analysis

Technical communication

Multitasking

Learning mindset

Education

Bachelor's degree in Engineering

Tools

CAD

Job description

This is whereyour 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 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.

WORK ENVIRONMENT

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.

Conditions and requirements include:

• Wearing a static protective smock and wrist strap while in designated areas.
• Working in close proximity to others in a temperature- and humidity-controlled environment.
• Compliance with cleanroom or ESD (electrostatic discharge) protocols as required.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $76,000-$104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits,

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

711 Park Avenue|Medina, NY 14103|United States of America