Senior quality assurance executive and certified Six Sigma Black Belt with over 20-year global career driving top-performing, compliant QA operations and continuous improvement for leading healthcare sector enterprises. Expertise in CAPA management and internal/external auditing with background in medical device and pharmaceutical quality design assurance. Consulting and remediation experience.
Recognized for improving products and quality management systems via end-to-end leadership of quality initiatives. Own investigation, review, approval, and closure of deviations, change controls, and CAPAs. Excel in identifying quality procedure workflow enhancements.
Establish shared vision of quality excellence; strengthen cross-functional collaboration and provide quality leadership to ensure product and material compliance with company standards/specifications. Orchestrate risk assessment evaluations and develop mitigation plans.
