Sr. Quality System Improvement Specialist
On-site · Covington, Georgia, United States
Job Summary
Senior role focused on leading and improving quality systems for complaint handling and metrics. Responsible for developing and communicating departmental metrics and trends, driving the implementation and continuous improvement of complaint handling systems and processes to ensure efficiency, standardization, and regulatory compliance. Oversees audit readiness, collaborates cross-functionally with Field Assurance and leadership, develops training materials and conducts onboarding for new employees and contractors, leads Kaizen and PSP activities using root cause analysis and process mapping, and helps drive data-driven quality improvements across the organization.
Required Qualifications
- Bachelor’s degree in Science, Engineering, or related discipline
- minimum of five (5) years of relevant technical experience
- minimum of four (4) years of experience in an FDA-regulated industry, including hands-on experience in complaint handling and investigation processes
- strong understanding of Corporate and Site Quality Systems
- ability to lead Kaizen events, facilitate PSP activities, and drive cross-functional alignment
- experience with data analysis tools (Excel, Minitab, Power BI) and complaint handling systems (TrackWise)
- excellent interpersonal, communication, and facilitation skills
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