Manager, Quality Engineering
Baxter · Round Lake, IL
- Level
- Manager
- Team
- Quality
- Base pay
- $112k–$154k
- Degree
- Required
- Industry
- Medical devices
- Posted
- 29 days ago
The role in 30 seconds
A management quality role at Baxter (medical devices) in Round Lake, IL. Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project risk, complexity, and business priority.
- They ask for
- degree required
- Tools it names
- Six Sigma, FDA / GMP, Validation (IQ/OQ/PQ)
- Base pay
- $112k–$154k
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in Illinois: typical posted base $98k–$146k. This one lists $112k–$154k.
Median of the low and high ends of 36 live postings that list pay, out of 46 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 45 other live quality postings in Illinois.
- Base pay
- About 17% above similar roles
- Experience asked
- Not stated
Typical $96k–$132k, from 30 postings that list pay.
Similar roles usually ask 4+ years.
Skills these teams ask for most
- ✓ Validation (IQ/OQ/PQ) 50%
- Root cause 43%
- Supplier quality 43%
- Team leadership 37%
- SPC 35%
- ✓ FDA / GMP 35%
✓ = this posting asks for it too. % = share of similar postings that mention it.
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
7 other open roles at this site.
- Manufacturing Manager · Manufacturing · Manager
- Senior Engineer, Quality · Quality · Senior
- Plant Utilities Maintenance Technician (Night Shift) · Reliability · Technician
- Manufacturing Supervisor II · Manufacturing · Supervisor
- Automation Technician · Controls · Technician
- Sr Calibration Technician · Quality · Technician
Full description from BaxterAs posted on their careers site.ShowHide
Responsibilities
- ◆Establish and maintain the site strategy, governance model, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity.
- ◆Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project risk, complexity, and business priority.
- ◆Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain clear accountability for validation authoring and execution, technical operation, vulnerability remediation, and sustained control effectiveness.
- ◆Approve or delegate approval of validation master plans, high-risk protocols and reports, critical deviations, revalidation strategies, major change controls, and continued use or release decisions.
- ◆Chair or sponsor validation and data integrity governance forums; set risk-based priorities across the plant system inventory and resolve multi-functional ownership or resource conflicts.
- ◆Ensure the data integrity program is aligned with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations.
- ◆Review program health through metrics, audits, periodic reviews, remediation aging, deviation trends, audit-trail-review performance, and effectiveness checks; raise risks to site leadership.
- ◆Ensure remediation plans have accountable operational owners, appropriate milestones, interim controls, documented risk acceptance, and independent QA verification of sustainable closure.
- ◆Represent validation and data integrity programs, in partnership with system owners, during FDA and other regulatory inspections, customer audits, governance reviews, and regulatory submissions.
- ◆Develop capability, succession plans, training, and standardized tools for Quality Engineering and multi-functional partners.
- ◆Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence.
Qualifications
- ✓Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, quality systems, and contemporary regulatory expectations.
- ✓Demonstrated people leadership and ability to build high-performing technical teams.
- ✓Proven capability in organizing plans, making decisions considering risks, governance, influencing, negotiation, and managing conflicts.
- ✓Ability to maintain QA independence while creating effective partnerships with Engineering, Facilities, Operations, CSV, laboratories, and business leadership.
- ✓Excellent written and oral communication skills, including executive and regulatory presentations.
- ✓Proven success leading complex programs, inspections, remediation governance, and multi-functional organizational change.
- ✓Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.
- ✓Candidate must meet all applicable site safety and occupational requirements.
Education and/or Experience
- ✓Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field required.
- ✓8 or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership.
- ✓Prior experience participating in regulatory inspections and complex remediation programs desired.
- ✓ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable.
We understand com
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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 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.
Summary
You will lead the Quality Engineering function, providing independent oversight of the site validation program and governance of the plant data integrity program. The Quality Engineering Manager establishes strategy, standards, risk tolerance, and performance expectations to ensure compliance with regulatory and quality requirements. You will build strong partnerships with Engineering, Facilities, Operations, CSV, laboratories, and system owners to support effective program execution.
As the primary Quality representative for validation and data integrity programs, you will interface with site leadership and regulatory agencies. The Quality Engineering Manager ensures validation and remediation activities are executed by accountable owners while maintaining independent Quality oversight through review, approval, escalation, and governance.