Quality Associate III

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 its 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 theres 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.

What youll be doing

• 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 Baxters eQMS platforms.
• Raise significant quality issues overdue commitments adverse trends or potential compliance risks through established site and corporate quality governance processes.
  

What youll bring

• Bachelors 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.
• 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.
  

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 $96000 - $132000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant 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 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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