Quality Systems Specialist

Zvh; Saint Paul (MN); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health and dental coverage

401(k) Plan with company match

Employee stock purchase program (ESPP)

Paid time off 20–35 days

Job summary

Baxter is seeking a Quality Systems Specialist to ensure quality, safety, and reliability of products across manufacturing, engineering, and regulatory teams. You will drive change control, investigations, audits, and CAPAs while supporting cross-site quality initiatives and continuous improvement.

The role requires a Bachelor's degree in a technical field and 5+ years in a regulated manufacturing environment, with knowledge of FDA QSR/ISO 13485.

Qualifications

• Bachelor's degree in a related technical field.
• 5+ years in medical device/pharma/regulated manufacturing quality systems.
• Experience managing CAPAs, nonconformance investigations, change controls, audits.
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and quality risk management.
• Strong writing, documentation review, and project prioritization skills.

Responsibilities

• Lead quality review and approval activities for change control records with risk assessments and implementation plans.
• Own and coordinate nonconformance investigations and CAPAs for timely root-cause analysis.
• Partner with cross-functional teams to resolve quality issues and maintain regulatory compliance.
• Review manufacturing, inspection, and release docs to support product disposition decisions.
• Support audits by preparing documentation and gathering evidence for outcomes.
• Monitor quality metrics, identify trends, and escalate issues impacting compliance or product quality.
• Serve as a quality systems SME, supporting document control and continuous improvement across sites.

Skills

Quality systems

Regulatory compliance

Root cause analysis

Documentation

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in related field

Tools

TrackWise

Adobe approvals

ERP systems

Job description

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.

Quality Systems Specialist

Join Baxter and help ensure the quality, safety, and reliability of products that impact patients and healthcare providers around the world. As a Quality Systems Specialist, you will serve as a critical quality partner supporting change control, investigations, audits, product disposition, and quality system effectiveness. Based within our Quality organization, this role works across manufacturing, engineering, regulatory affairs, and supplier quality teams to maintain compliance, drive continuous improvement, and support business continuity. If you're passionate about solving complex quality challenges and influencing outcomes that matter, this is an opportunity to make a meaningful impact.

What You'll Be Doing

• Lead quality review and approval activities for change control records, ensuring risk assessments, supporting evidence, and implementation plans meet established quality requirements.
• Own and coordinate nonconformance investigations and Corrective and Preventive Actions (CAPAs), driving timely root cause analysis and sustainable corrective actions.
• Partner with cross-functional teams to resolve quality issues, improve processes, and maintain compliance with regulatory and corporate quality standards.
• Review manufacturing, inspection, and release documentation to support product disposition decisions and ensure products meet quality requirements before release.
• Support internal, customer, regulatory, and notified body audits by preparing documentation, gathering evidence, and contributing to successful audit outcomes.
• Monitor quality system performance metrics, identify trends and risks, and proactively escalate issues that could impact compliance, product quality, or business operations.
• Serve as a quality systems subject matter expert, supporting document control activities, procedural updates, and continuous improvement initiatives across multiple sites.

What You'll Bring

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry, or a related technical field, or an equivalent combination of education and directly related experience in a regulated manufacturing environment.
• 5+ years of experience supporting quality systems within the medical device, pharmaceutical, biotechnology, or combination product industries.
• Experience managing CAPAs, nonconformance investigations, change controls, audit activities, and continuous improvement initiatives.
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, and quality risk management principles.
• Demonstrated ability to conduct investigations, analyze data, solve complex problems, and communicate recommendations effectively across functions.
• Strong technical writing, documentation review, organizational, and project prioritization skills.
• Ability to travel up to 10% as needed to support audits, remediation activities, and multi‑site quality initiatives.

Preferred Qualifications

• Lead Auditor certification or demonstrated experience supporting internal, external, customer, or regulatory audits.
• Experience supporting multiple manufacturing sites within a regulated environment.
• Familiarity with electronic Quality Management Systems (eQMS), including TrackWise, Adobe approval workflows, and ERP platforms.
• Experience supporting product release and product complaint processes.
• Ability to work independently, manage competing priorities, and effectively influence stakeholders across various levels of the organization.

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.

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.

US Benefits at Baxter (except for Puerto Rico)

This 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.

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.

Know Your Rights: Workplace Discrimination is Illegal

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, you may let us know the nature of your request and contact information.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.