Quality Associate II

Quality Investigation Lead 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. 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. Know Your Rights: Workplace Discrimination is Illegal 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 Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.