Quality Associate III

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 Senior Quality Investigation Lead, you will serve as a recognized subject matter expert within Baxter's Quality-led investigation program. You will independently lead high-risk, systemic, recurring, and cross-functional investigations while partnering with leaders and technical experts to evaluate evidence, assess product impact, identify root causes, and develop effective corrective and preventive actions.

Beyond individual case ownership, you will help strengthen the overall investigation program through investigator coaching, case calibration, continuous improvement initiatives, and identification of broader quality trends. Your ability to navigate ambiguity, challenge assumptions, and communicate complex technical findings will help ensure quality decisions are objective, defensible, and aligned with patient safety and regulatory expectations.

What You'll Be Doing

• Lead complex, high-risk, systemic, and cross-functional investigations from initiation through independent Quality approval, ensuring timely and comprehensive resolution.
• Develop investigation strategies, evidence plans, risk assessments, and decision frameworks that support accurate root cause determination and product impact evaluation.
• Direct multidisciplinary teams through evidence collection, technical analysis, hypothesis testing, and scientific problem-solving activities.
• Evaluate quality, manufacturing, laboratory, supplier, engineering, and electronic system data to identify root causes, systemic vulnerabilities, and opportunities for preventive action.
• Facilitate senior-level discussions that drive alignment on investigation findings, risk assessments, product impact evaluations, and corrective action strategies.
• Author and present investigation reports, executive summaries, and technical conclusions during internal audits, customer audits, and regulatory inspections.
• Mentor and coach investigators, contribute to calibration activities, and support the development of investigation capabilities across the organization.

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; an equivalent combination of relevant regulated-industry experience may be considered through an approved equivalency process.
• 5+ years of progressive experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
• 3+ years of experience leading formal investigations, including ownership of complex, recurring, systemic, or high-risk quality events.
• Demonstrated expertise in cGMP regulations, Good Documentation Practices, quality risk management, CAPA systems, data integrity, and investigation methodologies.
• Proven ability to evaluate complex technical evidence, conduct product impact assessments, determine defensible root causes, and develop sustainable corrective and preventive actions.
• Strong technical writing, analytical reasoning, facilitation, project leadership, coaching, and conflict-resolution skills.
• Experience communicating technical and compliance-related information to senior leadership, auditors, inspectors, and cross-functional stakeholders.
• Proficiency with electronic Quality Management Systems (eQMS), such as TrackWise, and data analysis or reporting tools.

Preferred Qualifications

• Advanced degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline.
• Experience defending investigations and presenting conclusions during FDA, Health Canada, customer, or other regulatory inspections.
• Demonstrated experience integrating manufacturing, laboratory, engineering, supplier, complaint, and quality-system data to identify broader systemic risks.
• Lean Six Sigma Green Belt or Black Belt certification.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality credential.
• Experience coaching investigators, conducting peer reviews, leading calibration sessions, or supporting investigator qualification programs.

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