Quality Engineer II - Validation

Baxter · Round Lake, IL

Level: Engineer
Team: Quality
Base pay: $88k–$121k
Degree: Required
Experience asked: 3+ years
Industry: Medical devices
Posted: Yesterday

The role in 30 seconds

An engineer-level quality role at Baxter (medical devices) in Round Lake, IL. , you will collaborate with cross-functional stakeholders to assess risk, review critical documentation, support inspection readiness, and verify that quality systems remain effective and compliant.

They ask for: 3+ years · degree required
Tools it names: FDA / GMP, Validation (IQ/OQ/PQ)
Base pay: $88k–$121k

Read from the posting. The full description is below.

From the plant jobs report · week of November 2, 2026

Quality Engineer roles in Illinois: typical posted base $96k–$127k. This one lists $88k–$121k.

Median of the low and high ends of 49 live postings that list pay, out of 66 quality engineer openings in Illinois, read from manufacturers' own careers sites.

Illinois plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 65 other live quality postings in Illinois.

Base pay: In line with similar roles
Experience asked: Less than usual (3+ vs 5+)

Skills these teams ask for most

Root cause 56%
Supplier quality 47%
✓ Validation (IQ/OQ/PQ) 45%
SPC 38%
FMEA 35%
Team leadership 35%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

At a glance

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

1
Pick 2–3 people on the Quality team at Baxter
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: Baxter in Round Lake

5 other open roles at this site.

Manufacturing Manager · Manufacturing · Manager
Senior Engineer, Quality · Quality · Senior
Automation Technician · Controls · Technician
Manager, Quality Engineering · Quality · Manager
Director, Design Quality - Infusion Systems · Quality · Director+

Full description from BaxterAs posted on their careers site.Show

Your Role at Baxter

As a Quality Assurance Validation & Data Integrity Specialist, you will serve as an independent quality partner responsible for providing oversight and guidance across validation, qualification, and data integrity activities. You will help ensure regulatory compliance throughout the lifecycle of equipment, facilities, utilities, manufacturing processes, cleaning programs, and computerized systems.

In this role, you will collaborate with cross-functional stakeholders to assess risk, review critical documentation, support inspection readiness, and verify that quality systems remain effective and compliant. Your work will influence operational excellence, regulatory readiness, and the consistent delivery of products that improve and save lives.

Required Qualifications

✓Bachelor's degree in Engineering, Science, Computer Science, or a related technical discipline.
✓3+ years of experience in Quality Assurance, Validation, Quality Engineering, Computerized Systems Validation, Data Integrity, Laboratory Systems, or a related role within a cGMP-regulated industry.
✓Working knowledge of cGMP regulations, GAMP 5 principles, 21 CFR Part 11 requirements, ALCOA+ data integrity principles, and risk-based quality management practices.
✓Experience independently reviewing validation protocols, qualification documents, reports, deviations, change controls, and compliance assessments.
✓Strong analytical, technical, and problem-solving skills with the ability to evaluate risk and make sound quality decisions.
✓Ability to influence and collaborate effectively across multiple functions while maintaining independent quality oversight and judgment.
✓Strong written and verbal communication skills with the ability to clearly communicate compliance risks and recommendations to stakeholders and leadership.

Preferred Qualifications

✓Experience supporting regulated computerized systems and computerized system lifecycle activities.
✓Familiarity with eQMS platforms, audit trail review programs, electronic records controls, and validation management processes.
✓Experience supporting regulatory inspections, audits, or inspection readiness activities.
✓Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), or similar credentials.
✓Demonstrated experience coaching colleagues or leading quality-related continuous improvement initiatives.

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)

Show full description ↓

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.

What You'll Be Doing

•Provide quality assurance leadership for validation and qualification projects by partnering with stakeholders from initial risk assessment through final approval and project closure.
•Review and approve validation, qualification, and lifecycle documentation to ensure compliance with cGMP requirements, quality standards, and regulatory expectations.
•Evaluate change controls, validation impact assessments, periodic reviews, and revalidation strategies to support risk-based and compliant decision-making.
•Assess and approve quality-related electronic quality management system (eQMS) records while ensuring clear accountability with process, engineering, laboratory, and system owners.
•Lead data integrity assessments and compliance reviews, identify opportunities for improvement, verify corrective actions, and strengthen sustainable controls.
•Analyze trends in validation deviations, data integrity observations, and quality system metrics to proactively identify risks and recommend appropriate escalation.
•Support regulatory inspections and audits by providing subject matter expertise, preparing inspection-ready documentation, and coaching cross-functional teams on validation and data integrity expectation

What You'll Bring