Quality Associate 3 Investigations - Nonconformance/CAPA

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, recurring, systemic, multi-lot, multi-product, or cross-functional investigations from intake through independent Quality approval.
• Establish risk tier, scope, evidence strategy, decision points, milestones, and escalation needs; expand or redirect the investigation when evidence warrants.
• Direct collection and preservation of original evidence across manufacturing, laboratory, engineering, supplier, complaint, computerized-system, and quality-system sources.
• Lead rigorous hypothesis generation and falsification, including selection of discriminating tests, technical studies, statistical analyses, and cross-functional case conferences.
• Determine and defend direct, contributing, and root causes; identify systemic control weaknesses and clearly document uncertainty, limitations, and alternative explanations.
• Lead comprehensive product-impact and extent assessments covering affected and potentially affected lots/products, distributed product, process state, data integrity, patient/user risk, and related or historical events.
• Develop and challenge cause-linked CAPA strategies, emphasizing sustainable systemic controls, clear implementation evidence, change-risk management, and objective effectiveness criteria.
• Facilitate senior-level cross-functional decision making, resolve technical disagreements where possible, and escalate unresolved risk, evidence obstruction, integrity concerns, market-impact potential, or resource conflicts.
• Author and defend complex investigation reports and executive summaries; ensure the record is accurate, evidence-linked, internally consistent, and understandable to an informed independent reviewer.
• Present investigation strategy, evidence, causal logic, impact, and CAPA rationale during internal audits, customer audits, and regulatory inspections.
• Coach Investigation Lead II personnel and trainees; perform peer reviews, lead case calibration, provide actionable feedback, and support simulations, supervised cases, and qualification assessments when authorized.
• Analyze investigation quality, recurrence, rework, aging, and process trends; recommend improvements to procedures, taxonomy, templates, workflows, training, and governance.
• Support workload planning and priority setting by advising the Investigation Program Lead on complexity, staffing, SME needs, and case risk.
• Manage a risk-adjusted portfolio within approved limits, including no more than the authorized number of concurrent high-risk cases without documented approval.

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.

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 $96,000 - $132,000 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. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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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.

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