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.

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

This is where your creativity addresses challenges!

As QA Engineering Lead you provide Quality Assurance leadership and oversight for engineering-related quality processes across medical device, solutions, and pharmaceutical manufacturing sites. This role ensures that validation, change control, metrology, utilities/facilities, and operational excellence activities are executed in compliance with applicable medical device, pharmaceutical, and combination-product regulations and standards, while enabling efficient, reliable, and scalable operations. The role partners closely with Engineering, Manufacturing, Operations, IT, Regulatory Affairs, and Quality teams to ensure that technical changes, systems, and infrastructure remain compliant, well controlled, and aligned with business objectives and patient safety requirements across regulated environments.

What you'll be doing

• Provide QA oversight and governance for validation, change control, and lifecycle management of equipment, processes, utilities, facilities, and computerized systems across medical device and pharmaceutical operations, ensuring compliance with global regulatory standards (FDA, ISO, EU GMP, ICH, GAMP).
• Review and approve validation, qualification, calibration, and change control documentation, ensuring systems remain in a state of control and risks to product quality, patient safety, and compliance are effectively managed.
• Support new product introductions, technology transfers, automation, digital solutions, and facility expansions, partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives.
• Oversee critical utilities, facilities, and metrology programs, ensuring systems are qualified, maintained, monitored, and inspection‑ready, with appropriate mitigation of deviations and out‑of‑tolerance conditions.
• Act as a key Quality partner during audits and inspections, drive standardization and simplification of QA Engineering processes, provide coaching and guidance to technical teams, and influence quality outcomes in a matrixed environment.

What you'll bring

• Bachelor’s degree in Engineering or similar
• 7+ years of experience in Quality, Engineering, Validation, or Manufacturing within regulated medical device and/or pharmaceutical environments
• Strong working knowledge of validation/CSV, change control, utilities and facilities qualification, and quality systems
• Experience supporting regulatory inspections and audits

Preferred

• Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, ICH Q7, and GAMP 5
• Experience supporting combination products or multi-platform manufacturing sites
• Familiarity with lean, continuous improvement, or business excellence systems in regulated environments

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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