Quality Systems Specialist

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.

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 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.

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