New · posted Nov 6
Baxter · Medical Devices
Quality Associate II
- 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 Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; equivalent combinations of education and directly relevant regulated-industry experience may be considered.
- 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
- 2+ years of experience leading or significantly contributing to investigations, deviations, nonconformances, customer complaints, CAPAs, or related quality processes.
- Working knowledge of cGMP regulations, Good Documentation Practices, quality systems, CAPA principles, quality risk management, and data integrity requirements.
- Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, evidence-based conclusions.
- Strong analytical thinking, technical writing, project management, facilitation, interviewing, and problem-solving skills.
- Ability to collaborate effectively across functions, influence without direct authority, manage competing priorities, and communicate risks clearly.
- Experience using Microsoft Office applications and electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.
Preferred Qualificationsnice to have
- Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
- Knowledge of investigation methodologies such as 5 Whys, Fishbone/Ishikawa Analysis, Fault Tree Analysis, DMAIC, process mapping, and quality risk assessment.
- Experience utilizing data visualization, reporting, or statistical analysis tools to support quality investigations and trend analysis.
- Lean Six Sigma Green Belt certification or equivalent process improvement experience.
- ASQ certification or related quality credential.
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.
What you'll do
Your Role at Baxter
As a Quality Investigation Lead, you will serve as a key contributor within Baxter's Quality-led investigation program. You will independently manage investigations from initiation through completion, applying structured problem-solving techniques, objective evidence evaluation, and risk-based decision making to determine causes and support effective resolution.
In this role, you will collaborate with cross-functional subject matter experts, assess product and patient impact, recommend sustainable corrective and preventive actions, and ensure investigation records are complete, compliant, and inspection ready. Your success will be measured by the quality of your investigations, the effectiveness of your recommendations, and your ability to drive timely resolution of quality events that support operational excellence and patient safety.
- Lead quality investigations for deviations, nonconformances, complaints, and other quality events, ensuring timely execution in accordance with risk-based quality processes and regulatory requirements.
- Analyze manufacturing, laboratory, engineering, and quality-system data to identify facts, evaluate evidence, and develop well-supported conclusions.
- Develop and test multiple hypotheses to determine direct, contributing, and root causes using proven investigation and problem-solving methodologies.
- Assess actual and potential impact to products, processes, data, and patients while supporting risk-based quality decisions and product disposition activities.
- Partner with cross-functional subject matter experts to gather evidence, resolve issues, drive alignment, and execute investigation plans.
- Recommend corrective and preventive actions (CAPAs) that address identified causes, reduce risk, and support long-term process improvement.
- Create clear, thorough, and inspection-ready investigation reports while maintaining accurate records within the electronic Quality Management System (eQMS).
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 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Illinois5 roles publishing pay
Senior & Principal roles in the US64 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $88,000 | — | $121,000 |
| Illinois (middle half) | $114,000 | $114,000 | $130,000 |
| All US (middle half) | $92,500 | $115,500 | $152,750 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 343 open Quality Assurance 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 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA11
- Quality systems and risk6
- Collaboration and leadership6
- Lab testing and methods5
- GMP and compliance4
- Documentation and SOPs4
- Data and digital systems3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in medical devices, led by the three 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
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)Named 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
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
Company hiring pulse
Baxter on Regulatory Jobs
- 47
- Open roles
- 47
- Distinct roles
- 11
- Locations
By discipline
- Quality43 90%
- Regulatory5 10%
By level
- Associate & Specialist21 44%
- Senior & Principal11 23%
- Manager8 17%
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Quality Associate II at Baxter
Open until filled. $88K–$121K a year, employer provided.