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,…