Frank S.
Quality Engineer @Agora Edge
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WORK HISTORY
Quality Engineer @Agora Edge
Tampa/St. Petersburg, FL, US
Manage ISO 13485 quality system; develop and implement policies aligned with ISO 9001, FDA GMP, and MDD.Lead internal audits, management reviews, and supplier quality programs to ensure compliance and continuous improvement.Investigate quality issues, perform root cause analysis, and implement CAPA to prevent recurrence.Partner with customers to resolve quality concerns, reducing complaints year-over-year.Oversee inspection operations, create procedures, and train employees on measurement techniques and quality standards.Conduct process risk analysis (FMEA), develop control plans, and implement process controls for consistent product quality.Develop raw material and final inspection specifications; manage nonconforming product investigations.Key Achievements:Reduced Defective Parts Per Million (DPPM) by 5% annually, driving measurable quality improvement.Decreased customer complaints, strengthening client satisfaction and trust.Trained all employees on quality and safety standards within 60 days, ensuring organization-wide compliance.Onboarded and trained new inspectors, improving team competency and efficiency.Reduced non-conforming products, improving production reliability.Increased quality self-reliance across departments, empowering teams to maintain standards independently.Demonstrated self-awareness and continuous improvement, enhancing team performance and fostering a strong quality culture.
EDUCATION
University Santiago Mariño
Industrial Engineering
University José Antonio Páez
Quality & Productivity Graduate Certificate
St. Petersburg College
Lean Six-Sigma Green Belt, Engineering
Instituto Universitario de Nuevas Profesiones
Petroleum Technology Associate Degree
ABOUT FRANK S.
I am a Quality Engineer at Agora Edge, where I help ensure regulatory compliance and operational efficiency through expertise in ISO 13485, FDA GMP, and ISO 9001 standards. My role includes supporting internal audits, shaping policies, and facilitating management reviews to keep our team aligned with rigorous quality requirements. With over 10 years of experience in quality control and food safety, I specialize in continuous improvement and proactive problem-solving. I’ve led corrective and preventive actions to resolve customer concerns, strengthen processes, and drive long-term improvements. As a Lean Six Sigma Green Belt, I bring a structured approach to enhancing supplier quality management and inspection strategies. My focus is on fostering a culture of compliance and excellence—ensuring customer satisfaction, reliable products, and sustainable operational integrity.
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