New · posted Nov 5
Baxter · Medical Devices
Quality Engineer II - Validation
- Round Lake, IL
- On-site
- Full-time
- Senior & Principal
The role
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 need
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 Qualificationsnice to have
- 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.
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 $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on 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, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
Skills named in this posting
What you'll do
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.
- 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
Pay
$88,000 – $121,000 a year
Employer providedThis 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. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Where you'll work
Round Lake, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Round Lake, ILEqual opportunity, accessibility and legal noticesBaxter's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% below the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in the US37 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $88,000 | — | $121,000 |
| All US (middle half) | $105,500 | $123,000 | $137,500 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 98 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Data and digital systems10
- Validation and qualification9
- Collaboration and leadership8
- Quality systems and risk7
- Documentation and SOPs6
- Lab testing and methods3
- Investigations and CAPA2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in medical devices, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systemsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ASTMASTM F1980(official source, opens in a new tab)Accelerated aging of sterile barrier systems and medical devices
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
Company hiring pulse
Baxter on Regulatory Jobs
- 44
- Open roles
- 40
- Distinct roles
- 11
- Locations
By discipline
- Quality39 89%
- Regulatory5 11%
By level
- Associate & Specialist19 43%
- Senior & Principal9 20%
- Manager8 18%
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Quality Engineer II - Validation at Baxter
Open until filled. $88K–$121K a year, employer provided.