Quality Associate 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 Investigation Lead, you will serve as a key contributor within Baxter's Quality-led investigation program. You will independently manage investigations from initiation through completion, applying structured problem-solving techniques, objective evidence evaluation, and risk-based decision making to determine causes and support effective resolution.

In this role, you will collaborate with cross-functional subject matter experts, assess product and patient impact, recommend sustainable corrective and preventive actions, and ensure investigation records are complete, compliant, and inspection ready. Your success will be measured by the quality of your investigations, the effectiveness of your recommendations, and your ability to drive timely resolution of quality events that support operational excellence and patient safety.

What You'll Be Doing

• Lead quality investigations for deviations, nonconformances, complaints, and other quality events, ensuring timely execution in accordance with risk-based quality processes and regulatory requirements.
• Analyze manufacturing, laboratory, engineering, and quality-system data to identify facts, evaluate evidence, and develop well-supported conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using proven investigation and problem-solving methodologies.
• Assess actual and potential impact to products, processes, data, and patients while supporting risk-based quality decisions and product disposition activities.
• Partner with cross-functional subject matter experts to gather evidence, resolve issues, drive alignment, and execute investigation plans.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, reduce risk, and support long-term process improvement.
• Create clear, thorough, and inspection-ready investigation reports while maintaining accurate records within the electronic Quality Management System (eQMS).

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; equivalent combinations of education and directly relevant regulated-industry experience may be considered.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
• 2+ years of experience leading or significantly contributing to investigations, deviations, nonconformances, customer complaints, CAPAs, or related quality processes.
• Working knowledge of cGMP regulations, Good Documentation Practices, quality systems, CAPA principles, quality risk management, and data integrity requirements.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, evidence-based conclusions.
• Strong analytical thinking, technical writing, project management, facilitation, interviewing, and problem-solving skills.
• Ability to collaborate effectively across functions, influence without direct authority, manage competing priorities, and communicate risks clearly.
• Experience using Microsoft Office applications and electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.

Preferred Qualifications

• Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
• Knowledge of investigation methodologies such as 5 Whys, Fishbone/Ishikawa Analysis, Fault Tree Analysis, DMAIC, process mapping, and quality risk assessment.
• Experience utilizing data visualization, reporting, or statistical analysis tools to support quality investigations and trend analysis.
• Lean Six Sigma Green Belt certification or equivalent process improvement experience.
• ASQ certification or related quality credential.

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. …