Quality Systems Specialist

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Parental leave

Employee stock purchase plan

Job summary

At Baxter, a Quality Systems Specialist ensures the quality, safety, and reliability of medicines and medical devices. You will partner across manufacturing, engineering, regulatory affairs, and supplier quality to maintain the QMS, lead investigations, CAPAs, audits, and product disposition.

Based in our Quality organization, you will drive continuous improvement, support audits, and ensure compliance with global standards while enabling timely, high-quality product releases to patients and

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry, or related field.
• 5+ years of experience supporting quality systems in regulated manufacturing environments (medical device/pharma/biotech).
• Experience managing CAPAs, nonconformance investigations, change controls, audit activities, and continuous improvement.
• Strong knowledge of FDA QSR (21 CFR Part 820)/QMSR, ISO 13485, and quality risk management.
• Ability to conduct investigations, analyze data, and communicate recommendations across functions.
• Strong technical writing, documentation review, organizational, and project prioritization skills.
• Ability to travel up to 10% to support audits and cross-site quality initiatives.

Responsibilities

• Lead quality review and approval for change controls with risk assessments and evidence.
• Own and coordinate nonconformance investigations and CAPAs with root-cause analysis.
• Collaborate with cross-functional teams to resolve quality issues and ensure regulatory compliance.
• Review manufacturing, inspection, and release docs to support product disposition decisions.
• Prepare documentation for audits and support audit outcomes.
• Monitor quality system performance, identify trends, and elevate risks.
• Serve as SME for document control and continuous improvement across sites.

Skills

Quality systems

Investigations

CAPA management

Cross-functional collaboration

Regulatory knowledge

Technical writing

Project prioritization

Communication

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry or related field

Tools

TrackWise

Adobe approval workflows

ERP platforms

Job description

This is whereyour 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.

Your Role at Baxter

As a Quality Systems Specialist, you will play a key role in strengthening and sustaining Baxter's Quality Management System while ensuring compliance with global regulatory and industry standards. You will serve as a trusted quality partner, providing oversight and guidance across quality system processes, investigations, audits, and product release activities. Your ability to collaborate across functions, identify risks, and drive effective solutions will directly support operational excellence, regulatory readiness, and the delivery of safe, high-quality products to patients and customers.

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 elevate 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. 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.

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. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit the Benefits site.

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

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 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.

2575 University Avenue West|St Paul, MN 55114|United States of America