New · posted Nov 6
Baxter · Medical Devices
Quality Associate I — Quality Compliance
- Round Lake, IL
- On-site
- Full-time
- Associate & Specialist
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, Business, or a related field preferred; Associate degree with relevant experience or an equivalent combination of education and regulated-industry experience may be considered.
- 0-2 years of experience in Quality, Compliance, pharmaceutical manufacturing, medical device manufacturing, laboratory operations, engineering, document control, training, or another regulated environment.
- Strong organizational skills with exceptional attention to detail and commitment to accurate documentation.
- Ability to manage multiple priorities, follow established procedures, meet deadlines, and escalate concerns when appropriate.
- Strong written and verbal communication skills with the ability to collaborate effectively across teams and functions.
- Proficiency in Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
- Willingness and ability to learn new quality processes, systems, and regulatory requirements.
Preferred Qualificationsnice to have
- Foundational knowledge of cGMP regulations, Good Documentation Practices (GDP), quality systems, or data integrity principles.
- Experience supporting document control, training administration, investigations, audits, compliance activities, or quality reporting.
- Exposure to regulated manufacturing environments such as pharmaceutical, biotechnology, medical device, food, or related industries.
- Familiarity with electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.
- Experience supporting continuous improvement projects, process mapping activities, or quality metrics reporting.
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 $68,000 - $93,500 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 Systems & Compliance Associate, you will provide flexible support across Quality Systems, Compliance, Investigations, and related quality programs. Rather than focusing on a single specialty area, you will gain exposure to a variety of quality processes that are essential to maintaining regulatory compliance and operational excellence.
In this developmental role, you will support quality records, documentation, investigations, audits, reporting, training, and improvement initiatives while learning how quality systems work together to protect patients, products, and business performance. Success will be measured through accuracy, attention to detail, effective collaboration, and your ability to contribute to quality processes that support Baxter's commitment to excellence.
- Support Quality Management System (QMS) processes by maintaining records, tracking activities, and assisting with change controls, CAPAs, complaints, nonconformances, audits, and other quality programs.
- Enter, update, review, and manage information within electronic quality systems, ensuring records remain accurate, complete, timely, and inspection ready.
- Gather documentation, training records, manufacturing records, and other objective evidence to support investigations, audits, compliance activities, and quality decisions.
- Track action items, due dates, training completions, and record status while proactively communicating potential delays or risks.
- Compile, verify, and organize quality data used for dashboards, management reviews, trend reports, inspections, and continuous improvement initiatives.
- Support internal, customer, corporate, and regulatory audits by coordinating documentation, preparing evidence packages, and assisting with inspection readiness activities.
- Contribute to process improvements, documentation updates, training coordination, and cross-functional projects that strengthen quality system effectiveness.
Pay
$68,000 – $93,500 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 7% below the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $68,000 | — | $93,500 |
| All US (middle half) | $70,000 | $86,500 | $102,500 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 84 open Quality Systems & Document Control 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.
- Documentation and SOPs13
- GMP and compliance10
- Quality systems and risk9
- Collaboration and leadership8
- Investigations and CAPA5
- Data and digital systems3
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the two 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
- 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
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
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 I — Quality Compliance at Baxter
Open until filled. $68K–$94K a year, employer provided.