Quality Engineer II

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: Responsible for managing, maintaining and improving the Quality Management System processes, including CAPA, Internal and External Audits, Non-Compliant Product, Document Control, Quality Release, CAPA Board and Management Review, ensuring compliance with applicable regulatory, corporate and normative requirements. Will lead initiatives for continuous improvement, trend analysis and management of quality indicators to ensure the effectiveness of the Quality System and the fulfillment of business objectives. In addition, he supervises and develops the personnel assigned to the Quality Systems area, promoting a culture of quality, compliance and operational excellence. Identifies and evaluates gaps and systemic risks of the Quality System and leads Quality Plans and cross-functional remediation plans until their closure, effectiveness and sustainability are demonstrated. Applies knowledge of Quality Risk Management, Change Control and validation principles to evaluate impact and coordinate technical actions with Process Owners and Subject Matter Experts. What you will be doing: Manage the CAPA system, ensuring effective investigations, root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness. Coordinate and facilitate CAPA Board meetings, providing metrics, trend analysis, and action tracking. Manage the Non-Conforming Product system, ensuring the proper containment, investigation, disposition and monitoring of non-conforming materials or products. Plan, coordinate and execute the risk-based Internal Audit program. Coordinate the preparation and execution of external audits, certifications and regulatory inspections. Ensure the timely implementation and closure of corrective actions derived from internal, external and regulatory audits. Coordinate the Management Review process, preparing indicators, trends, metrics and reports for senior management. Manage the Document Control system, ensuring the creation, review, approval, distribution, and maintenance of controlled documents. Oversee the Quality Release process, ensuring that products meet all quality and regulatory requirements prior to release. Monitor key indicators of the Quality System, identify risks and opportunities for improvement and implement action plans. Maintain updated procedures, policies and records associated with the Quality Management System. Manage the CAPA system, ensuring effective investigations, root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness. Coordinate and facilitate CAPA Board meetings, providing metrics, trend analysis, and action tracking. Manage the Non-Conforming Product system, ensuring the proper containment, investigation, disposition and monitoring of non-conforming materials or products. Plan, coordinate and execute the risk-based Internal Audit program. Coordinate the preparation and execution of external audits, certifications and regulatory inspections. Ensure the timely implementation and closure of corrective actions derived from internal, external and regulatory audits. Coordinate the Management Review process, preparing indicators, trends, metrics and reports for senior management. Manage the Document Control system, ensuring the creation, review, approval, distribution, and maintenance of controlled documents. Oversee the Quality Release process, ensuring that products meet all quality and regulatory requirements prior to release. Monitor key indicators of the Quality System, identify risks and opportunities for improvement and implement action plans. Maintain updated procedures, policies and records associated with the Quality Management System. What will you bring? University Baccalaureate in Industrial Engineering, Chemistry, or related career. Minimum 3 years of experience in manufacturing, Quality Systems and Compliance. Experience in CAPA, audits, document control, non-conforming product and Quality Release. Advanced English (oral and written). Knowledge of regulations and quality management systems applicable to the industry. Knowledge of Quality Management Systems and applicable regulatory requirements. Knowledge of ISO 13485, ISO 9001, MDSAP, 21 CFR Part 820 and GMPs. Experience in CAPA, Audits, Non-Conforming Product, Document Control and Quality Release. Knowledge of root cause analysis and troubleshooting methodologies (5 Why, Fishbone, 8D, DMAIC). Experience in indicator management, trend analysis and risk assessment. Proficiency in Microsoft Office, especially advanced Excel. Knowledge of Artificial Intelligence tools applied to data analysis, process automation and continuous improvement Knowledge in Validations and Risk management 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. 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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