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Quality Associate III

$96k - $132k

Baxter Healthcare

Quality Associate III at Baxter provides senior-level oversight of Quality Management System processes including change control, CAPA, and complaints. The role serves as site subject matter expert, leads quality investigations, and partners across functions to ensure regulatory compliance and inspection readiness.

Responsibilities

  • Own or oversee Quality Management System processes including change control, CAPA, complaints, and nonconformance records
  • Lead complex quality investigations including complaint analysis, root cause determination, and corrective action development
  • Serve as site subject matter expert for assigned QMS workflows and inspection readiness
  • Prepare management review materials, dashboards, and trend reports on QMS performance
  • Partner cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and leadership to resolve quality system issues

Requirements

  • Senior-level quality management system experience with change control and CAPA processes
  • Demonstrated ability to lead complex quality investigations and root cause analysis
  • Strong cross-functional collaboration and communication skills
  • Knowledge of regulatory compliance requirements and inspection readiness
  • Proficiency with electronic quality management system (eQMS) platforms
  • Ability to analyze QMS metrics and prepare executive-level reports
Vacancy posted 4 days ago
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