Quality Engineer II

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. 

Your Role at Baxter

As a Quality Excellence Engineer, you will help drive the effectiveness and continuous improvement of Baxter's Quality Management System (QMS). This role combines quality systems expertise, risk-based decision-making, and cross-functional leadership to identify systemic gaps, implement sustainable solutions, and strengthen compliance across a highly regulated medical device environment.

You will influence key quality initiatives, collaborate with stakeholders across Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs, and help ensure our systems, processes, and culture continue to support product quality, patient safety, and operational excellence. Success in this role will be measured by your ability to reduce quality risks, improve process effectiveness, and deliver meaningful, lasting improvements to the QMS.

What You'll Be Doing

• Evaluate Quality Management System processes through assessments, audits, quality metrics, trend analysis, and other quality signals to identify systemic risks and improvement opportunities.
• Lead quality remediation plans and quality excellence initiatives, establishing clear objectives, timelines, governance structures, and measurable outcomes that drive sustainable improvement.
• Partner with cross-functional teams to implement corrective actions, strengthen compliance, and improve business processes while maintaining product quality and patient safety.
• Apply risk management principles to identify, assess, mitigate, and monitor quality risks that may impact regulatory compliance, operational continuity, or product quality.
• Monitor progress against remediation plans and quality initiatives, proactively identifying barriers, escalating risks, and ensuring commitments are achieved on time.
• Analyze trends, recurring quality issues, CAPAs, audits, nonconformances, and other quality data to uncover systemic opportunities for improvement.
• Drive inspection and audit readiness activities while helping foster a culture of accountability, continuous improvement, and quality excellence across the organization.

What You'll Bring

Required Qualifications

• Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
• 3+ years of experience in a regulated industry, preferably medical devices, within Quality Systems, Quality Engineering, Compliance, or related quality functions.
• Experience leading or supporting Quality Plans, remediation initiatives, complex CAPAs, quality system improvements, or gap assessments.
• Strong understanding of Quality Management Systems, GMP, ISO 13485, quality risk management, and regulatory compliance requirements.
• Proven ability to collaborate across functions, influence stakeholders, and coordinate initiatives without direct authority.
• Advanced English communication skills, both written and verbal.

Preferred Qualifications

• Training or certification in ISO 13485, ISO 14971, Quality Systems auditing, or Project Management.
• Experience supporting regulatory inspections, audit readiness programs, and remediation of regulatory findings.
• Knowledge of Lean, Six Sigma, or other continuous improvement methodologies.
• Experience driving quality culture initiatives, transformation programs, or Quality Excellence programs.
• Proficiency with Power BI, dashboards, and digital tools for quality analysis and performance tracking.

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

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