Investigation Lead 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 & CAPA Lead, you will serve as a key driver of quality excellence, leading investigations from initial assessment through completion and approval. You will evaluate evidence, challenge assumptions, test potential causes, and partner with cross-functional experts to determine the most effective path forward.

Your work will directly influence product quality, regulatory compliance, and operational performance by ensuring investigations are thorough, objective, timely, and inspection-ready. Success in this role requires strong analytical thinking, technical judgment, collaboration skills, and a commitment to making data-driven decisions that protect patients and customers.

What You'll Be Doing

• Lead quality investigations from intake through completion, ensuring timely, risk-based evaluation of quality events, deviations, complaints, or nonconformances.
• Analyze evidence from manufacturing records, laboratory data, interviews, process observations, and technical reports to identify findings and support objective conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using structured investigation and problem-solving methodologies.
• Partner with subject matter experts across Quality, Manufacturing, Engineering, Laboratory Operations, and other functions to gather evidence, align on findings, and drive effective solutions.
• Assess potential product, process, compliance, and patient impacts while supporting appropriate risk evaluations and disposition decisions.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, prevent recurrence, and include measurable indicators of effectiveness.
• Author clear, concise, inspection-ready investigation reports and maintain complete documentation 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, or an equivalent combination of education and directly relevant regulated-industry experience.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, laboratory, engineering, or quality operations in a regulated environment.
• 2+ years of experience leading or significantly contributing to formal investigations, deviations, nonconformances, customer complaints, or CAPA programs.
• Working knowledge of cGMP requirements, Good Documentation Practices, investigation processes, CAPA principles, quality risk management, and data integrity expectations.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, data-based conclusions.
• Strong technical writing, problem-solving, project management, facilitation, and communication skills.
• Experience working with electronic Quality Management Systems (eQMS), such as TrackWise, and Microsoft Office applications.

Preferred Qualifications

• Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
• Knowledge of structured problem-solving methodologies including 5 Whys, Fishbone/Ishikawa Analysis, DMAIC, Fault Tree Analysis, or similar approaches.
• Experience using reporting, visualization, or statistical analysis tools to identify trends and support decision making.
• Lean Six Sigma Green Belt, ASQ certification, or equivalent quality and process improvement credentials.
• Experience working in pharmaceutical, biotechnology, or medical device manufacturing environments with complex quality systems.

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. …