New · posted Nov 6
Baxter · Medical Devices
Quality Associate III
- 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; an equivalent combination of relevant regulated-industry experience may be considered through an approved equivalency process.
- 5+ years of progressive experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
- 3+ years of experience leading formal investigations, including ownership of complex, recurring, systemic, or high-risk quality events.
- Demonstrated expertise in cGMP regulations, Good Documentation Practices, quality risk management, CAPA systems, data integrity, and investigation methodologies.
- Proven ability to evaluate complex technical evidence, conduct product impact assessments, determine defensible root causes, and develop sustainable corrective and preventive actions.
- Strong technical writing, analytical reasoning, facilitation, project leadership, coaching, and conflict-resolution skills.
- Experience communicating technical and compliance-related information to senior leadership, auditors, inspectors, and cross-functional stakeholders.
- Proficiency with electronic Quality Management Systems (eQMS), such as TrackWise, and data analysis or reporting tools.
Preferred Qualificationsnice to have
- Advanced degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline.
- Experience defending investigations and presenting conclusions during FDA, Health Canada, customer, or other regulatory inspections.
- Demonstrated experience integrating manufacturing, laboratory, engineering, supplier, complaint, and quality-system data to identify broader systemic risks.
- Lean Six Sigma Green Belt or Black Belt certification.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality credential.
- Experience coaching investigators, conducting peer reviews, leading calibration sessions, or supporting investigator qualification programs.
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 $96,000 - $132,000 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 Senior Quality Investigation Lead, you will serve as a recognized subject matter expert within Baxter's Quality-led investigation program. You will independently lead high-risk, systemic, recurring, and cross-functional investigations while partnering with leaders and technical experts to evaluate evidence, assess product impact, identify root causes, and develop effective corrective and preventive actions.
Beyond individual case ownership, you will help strengthen the overall investigation program through investigator coaching, case calibration, continuous improvement initiatives, and identification of broader quality trends. Your ability to navigate ambiguity, challenge assumptions, and communicate complex technical findings will help ensure quality decisions are objective, defensible, and aligned with patient safety and regulatory expectations.
- Lead complex, high-risk, systemic, and cross-functional investigations from initiation through independent Quality approval, ensuring timely and comprehensive resolution.
- Develop investigation strategies, evidence plans, risk assessments, and decision frameworks that support accurate root cause determination and product impact evaluation.
- Direct multidisciplinary teams through evidence collection, technical analysis, hypothesis testing, and scientific problem-solving activities.
- Evaluate quality, manufacturing, laboratory, supplier, engineering, and electronic system data to identify root causes, systemic vulnerabilities, and opportunities for preventive action.
- Facilitate senior-level discussions that drive alignment on investigation findings, risk assessments, product impact evaluations, and corrective action strategies.
- Author and present investigation reports, executive summaries, and technical conclusions during internal audits, customer audits, and regulatory inspections.
- Mentor and coach investigators, contribute to calibration activities, and support the development of investigation capabilities across the organization.
Pay
$96,000 – $132,000 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 1% 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 | $96,000 | — | $132,000 |
| 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 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA14
- Collaboration and leadership9
- Quality systems and risk7
- Lab testing and methods6
- GMP and compliance5
- Data and digital systems4
- Documentation and SOPs3
- Clinical trial conduct3
- Validation and qualification1
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
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- 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
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 III at Baxter
Open until filled. $96K–$132K a year, employer provided.