Kimberly Bryant

• Conduct end-to-end investigations of customer complaints, adverse events, out-of-box failures, and 30-day repair failures for FDA-regulated medical devices, ensuring compliance with internal procedures, FDA regulations, and ISO 13485 requirements.
• Evaluate customer complaint information to determine investigation requirements, identify potential reportability, coordinate product evaluations, and document investigation findings through closure.
• Support Regulatory Affairs by providing complaint investigation documentation, technical assessments, adverse event evaluations, and quality records required for regulatory reporting and compliance activities.
• Lead complex root cause investigations utilizing 5 Whys, Fishbone, and cross-functional problem-solving methodologies while partnering with Engineering, Manufacturing, Service, and Regulatory Affairs to implement corrective and preventive actions.
• Prepare comprehensive technical investigation reports, complaint summaries, and customer resolution documentation supporting regulatory compliance and quality system requirements.
• Manage Nonconforming Material Reports (NCMRs), including investigations, root cause documentation, containment, and disposition support to ensure timely resolution.
• Perform QA final release reviews of medical devices and manufacturing quality records, including Manufacturing Record Review (DHR), AQL Sampling & Product Disposition Support.
• Serve as Lead Auditor, conducting internal quality system audits and supporting regulatory inspections by ensuring complaint documentation, investigations, and quality records comply with FDA and ISO requirements.
• Analyze complaint, repair, and quality data to identify recurring failure trends, monitor product performance, support management reviews, and recommend continuous improvement initiatives.
• Coordinate cross-functional Material Review Board (MRB) activities and perform risk-based analysis to support disposition decisions, identify emerging risks, and drive quality improvements.
• Create, revise, and maintain controlled quality documentation, work instructions, and technical procedures supporting manufacturing operations, Good Documentation Practices (GDP), and Acceptable Quality Level (AQL) requirements.

• Supervised Quality Technicians supporting incoming inspection, in-process audits, final product verification, and environmental monitoring of cleanroom and controlled areas, ensuring compliance with established quality and environmental requirements.
• Ensured raw materials, components, and finished devices met drawings, specifications, acceptance criteria, and applicable storage and environmental requirements, including temperature-controlled materials.
• Managed Nonconforming Material Reports (NCMRs), including investigations, root cause analysis, corrective and preventive actions, and disposition; tracked CAPA implementation and effectiveness through resolution.
• Presented quality and risk data during Material Review Board (MRB) reviews and developed nonconformance metrics and trend reports to support disposition decisions, identify recurring issues, and drive continuous improvement.
• Developed and improved mechanical, electrical, software, and functional test methods in accordance with ISO 13485 and FDA quality system requirements.
• Executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reviewed validation documentation to support compliant equipment, process, and system validation activities.
• Performed Computer System Validation (CSV) for QMS-related systems and software and supported change implementation activities, including review of applicable quality and validation documentation.
• Operated specialized test and inspection equipment and collaborated with Engineering and cross-functional teams to troubleshoot technical issues and improve test and manufacturing processes.
• Trained personnel in Geometric Dimensioning and Tolerancing (GD&T), inspection protocols, test methods, and quality documentation requirements while supporting audit readiness and regulatory compliance.
• Conducted investigations of nonconforming materials, documented root cause analyses, supported CAPA implementation, and collaborated with Engineering and Manufacturing to resolve quality issues.

Achievement: Progressively assigned expanded responsibilities across three quality functions, ultimately performing all concurrently while leading teams, driving process improvements, supporting CAPA execution, and strengthening compliance and audit readiness.

• Performed functional and visual inspections on refurbished electronics to ensure conformance to customer and ISO 9001 specifications.
• Documented and escalated nonconforming product issues, collaborating with engineering and operations teams to ensure timely resolution.
• Maintained inspection records and test reports, enhancing traceability and supporting audit readiness.
• Identified patterns in recurring defects and communicated findings to inform continuous improvement initiatives.

• Supervised quality inspectors across multiple production lines, ensuring adherence to inspection criteria and ISO 9001 standards, which upheld quality assurance.
• Led daily quality checks on in-process and finished goods, identifying deviations and coordinating corrective actions with manufacturing to maintain product integrity.
• Trained staff on inspection techniques and documentation practices, improving product quality and consistency across operations.
• Monitored trends in inspection results and contributed recommendations for process improvements, aiding in defect reduction efforts.

• Performed quality inspections and functional testing of damaged and refurbished electronics to verify product condition, functionality, and conformance with established requirements.
• Conducted hardware and software troubleshooting to identify defects, malfunctions, and component-level issues during testing.
• Utilized specialized test equipment and software to evaluate mobile device components, features, and functionality while maintaining accurate test and inspection records.
• Followed Standard Operating Procedures (SOPs), test protocols, and quality requirements to ensure consistent, accurate, and repeatable testing.
• Supported quality operations by identifying and documenting nonconforming product and communicating issues for appropriate resolution.
• Followed Standard Operating Procedures (SOPs), test protocols, and quality requirements to ensure consistent, accurate, and repeatable testing.
• Supported quality operations by identifying and documenting nonconforming product and communicating issues for appropriate resolution.