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Quality Assurance Officers

Baxter Healthcare

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. 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. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
You are creative, thorough, and a heads-down do-er. As a Quality Associate II, 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.
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.
This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. 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. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. This open dialog builds trust within the team and helps create a better product for our customers.
You will support complex QMS processes and serve as a knowledgeable resource for change control, CAPA, complaints, and nonconformance records. In this role you will lead routine quality investigations, contribute to metrics analysis and trend reporting, and support inspection readiness.
What you’ll be doing Lead routine quality investigations including root cause analysis using structured tools (5 Whys, Fishbone) and develop effective corrective/preventive actions.
Assess proposed changes for regulatory, product quality, and compliance impact; Support preparation of management review data packages, dashboards, and trend reports for assigned QMS elements.
Write, review, and revise SOPs, work instructions, and quality system documentation to ensure compliance with regulatory requirements.
Serve as a resource and subject matter expert for assigned QMS processes, providing guidance to process users and record owners.
Support internal audits, corporate audits, and regulatory inspections by preparing records, responding to requests, and participating in front-room activities.
Partner cross-functionally with Manufacturing, Engineering, QC, Regulatory Affairs, and other stakeholders to drive timely resolution of quality system issues.
Maintain inspection-ready records in Baxter's eQMS platforms; ensure data integrity and traceability.
Escalate significant quality issues, overdue commitments, or potential compliance risks through established governance processes.
Bachelor's degree in science, engineering, pharmacy, life sciences, quality, or related technical discipline required.
Minimum of 3 years of experience in Quality Assurance, Quality Systems, Quality Engineering, or Compliance in a regulated pharmaceutical, biotech, or medical device envi

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Vacancy posted 2 days ago
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