Quality Associate III

Baxter•Round Lake, IL

11d

About The Position

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 This is where your creativity addresses challenges You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Associate III, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. You will provide senior-level individual contributor ownership and oversight of Quality Management System processes including change control, CAPA, complaints, nonconformance records, and metrics, serving as site SME to ensure inspection readiness and regulatory compliance. Will also lead complex quality investigations, prepares management review materials, and partners cross-functionally to drive timely resolution of quality system issues while maintaining inspection-ready records in eQMS platforms. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

Requirements

Bachelor’s degree in science, engineering, pharmacy, life sciences, quality, regulatory affairs, or a related technical discipline.
4 plus years of experience in Quality Assurance, Quality Systems, Quality Engineering, Product Surveillance, Manufacturing Quality, or Compliance in a regulated pharma, biotech, or medical device environment.
Hands-on experience with at least two or more of the following QMS elements: change control, CAPA, nonconformance, complaints, deviations, audit readiness, management review, quality metrics, document control, supplier quality, or regulatory inspection support.
Prior experience serving as process owner, site SME, super user, reviewer, approver, or governance-board member for change control, CAPA, complaints, NCR, deviations, or management review.
Experience supporting FDA, ISO, notified body, corporate, customer, or health authority inspections.
Skilled in developing dashboards, KPI packages, process-health metrics, or management review materials using Excel, Power BI, SmartSheet, Tableau, or validated/eQMS reporting tools.
Proven ability to lead root cause analysis and investigations using structured tools such as 5 Whys, Fishbone/Ishikawa, fault tree analysis, DMAIC, risk assessment, or similar methodologies.
Experience using eQMS or quality data systems such as TrackWise, Veeva, MasterControl, ETQ, SmartSheet, Power BI, Excel, Tableau, TcU, SAP, or equivalent.
Strong technical writing skills with demonstrated ability to prepare clear, objective, inspection-ready investigation reports, quality assessments, executive summaries, metrics packages, and quality records.
Ability to lead multiple complex records, projects, and deadlines with limited supervision.
Strong communication, influencing, and cross-functional collaboration skills, including the ability to engage technical SMEs and site leadership.
Working knowledge of applicable regulations and standards such as FDA 21 CFR Part 820, 21 CFR 210/211, ISO 13485, EU MDR, ICH, cGMP, QSR, and/or global QMS requirements, depending on product scope.
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.

Nice To Haves

ASQ certification such as CQE, CQA, CMQ/OE, Six Sigma Green Belt/Black Belt, RAC, or equivalent quality/process-improvement credential preferred.
Experience in sterile drug product, combination product, device/drug-device, biologics, or high-volume regulated manufacturing environments preferred.
Demonstrated ability to simplify QMS processes while maintaining compliance, data integrity, traceability, and inspection readiness preferred.

Responsibilities

Own or provide senior-level oversight for assigned Quality Management System processes, which may include change control, CAPA, customer complaints, nonconformance records, metrics, management review inputs, and related eQMS workflows.
Serve as site SME for assigned QMS processes, including workflow routing, impact assessment, implementation planning, completion tracking, closure quality, and inspection readiness.
Lead or support complex quality investigations, including complaint investigations, nonconformance evaluations, root cause analysis, corrective/preventive action development, and effectiveness verification.
Assess proposed product, process, equipment, supplier, documentation, and quality system changes for regulatory, product quality, patient safety, data integrity, and business continuity impact.
Prepare, analyze, and report QMS metrics, including CAPA timeliness/effectiveness, complaint closure, aging records, change control execution, overdue actions, and adverse trends.
Develop management review-ready data packages, dashboards, trend reports, and executive summaries that clearly communicate QMS performance, risks, escalations, and recommended actions.
Partner cross-functionally with Manufacturing, Engineering, QC, Regulatory Affairs, Supplier Quality, Document Control, Medical/Clinical, and site leadership to drive timely and compliant resolution of quality system issues.
Support internal audits, corporate audits, customer audits, and regulatory inspections by preparing records, explaining process execution, supporting back-room/front-room activities, and responding to auditor requests.
Identify recurring QMS execution issues and lead continuous improvement initiatives to simplify workflows, improve right-first-time documentation, reduce cycle time, and strengthen compliance.
Provide coaching, training, and practical guidance to process users, record owners, CAPA owners, change owners, and cross-functional SMEs on QMS expectations and documentation quality.
Maintain inspection-ready records in Baxter's eQMS platforms.
Raise significant quality issues, overdue commitments, adverse trends, or potential compliance risks through established site and corporate quality governance processes.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits