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Key Highlights as a Product Quality Engineer:

  • 🔍 Ensured Regulatory Excellence: Conducted quality assurance and compliance checks for Alinity Laboratory Analyzers, ensuring adherence to FDA 21 CFR Part 820, Part 11, and ISO 13485 standards prior to release.

  • ⚙️ Root Cause & CAPA Management: Led Corrective and Preventive Actions (CAPA), tracked deviations, and managed non-conformance records to enhance product reliability.

  • 📋 Internal Audits & Compliance: Managed the internal audit program, including schedule planning, auditor training, and root cause analysis to address audit findings and ensure compliance.

  • 📂 Quality Management System (QMS): Oversaw document control, created and updated quality system templates, and streamlined approval workflows to maintain regulatory traceability.

  • 📦 Manufacturing Lot Release & Documentation: Monitored and supported product release processes, coordinating with production teams to verify accurate documentation and compliance readiness.

  • 🛠 Process Improvement & Optimization: Proactively contributed to continuous improvement initiatives, refining quality systems and optimizing product release workflows.

  • 📑 Regulatory Documentation & COAs: Maintained critical documentation, including product labels, lot records, and Certificates of Analysis (COAs), ensuring smooth and compliant product validation.

My work involved supporting the quality and reliability of diagnostic instruments across multiple customer sites, leading root cause investigations, implementing corrective actions, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 standards. I worked hands on with Abbott's Alinity Series! 

ALINITY c Clinical Chrmistry Laboratory Analyzer

  • Precision Quality Assurance: Conducted rigorous pre-release inspections and compliance checks, ensuring the Alinity i Immunoassay Analyzer met FDA 21 CFR Part 820, Part 11, and ISO 13485 standards before deployment.

  • Performance Optimization: Led root cause analysis and CAPA investigations, identifying and resolving non-conformances to enhance system reliability and diagnostic accuracy.

  • Enhancing Product Reliability: Implemented corrective actions and deviation tracking to improve system performance, ensuring consistent high-quality immunoassay results in clinical laboratories.

  • Cross-Functional Collaboration: Worked closely with manufacturing, R&D, and regulatory teams to streamline product release processes, optimize quality workflows, and troubleshoot technical challenges.

  • Regulatory Compliance & Documentation: Managed internal audits, document control, and Certificates of Analysis (COAs) to ensure full compliance with quality and regulatory standards.

  • Impact: Contributed to the successful manufacturing and release of a next-generation diagnostic system, improving efficiency, accuracy, and compliance in clinical laboratory testing worldwide.

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Key Strengths & Expertise:

Risk Management & Regulatory Compliance

  • ✅ Regulatory Compliance & Quality Assurance: Ensured adherence to FDA 21 CFR Part 820, Part 11, and ISO 13485 for Alinity i Immunoassay Laboratory Analyzers.

  • 📊 CAPA & Root Cause Analysis: Led Corrective and Preventive Actions (CAPA) and non-conformance investigations, identifying and resolving quality issues.

  • ⚖️ Risk Mitigation & Failure Mode Analysis: Utilized Failure Mode and Effects Analysis (FMEA), hazard analysis, and risk matrices to enhance product safety and performance.

  • 📑 Internal Audits & Documentation: Managed internal audit programs, conducted compliance evaluations, and authored Certificates of Analysis (COAs) to support regulatory requirements.

  • 🔄 Process Improvement & Risk Mitigation: Implemented quality system enhancements to streamline product release workflows and reduce manufacturing deviations.

  • 🔍 Deviation Tracking & Non-Conformance Reporting: Proactively monitored and resolved quality deviations, ensuring manufacturing and product consistency.​

Product Development & Quality Optimization

  • 🏭 Manufacturing Lot Release: Coordinated with production teams to ensure accurate documentation and regulatory-ready product launches.

  • 🛠 Product Reliability & Performance Enhancement: Monitored system reliability, performed failure analysis, and implemented corrective actions for consistent diagnostic accuracy.

  • 📂 Quality Management System (QMS): Managed document control, streamlined approval workflows, and optimized traceability for regulatory documentation.

  • ⚙️ Test Method Development & Validation: Designed and validated test protocols, ensuring accurate performance assessments in compliance with industry standards.

  • 🔬 Metrology & Precision Measurement: Applied calibration techniques and metrology principles to verify product specifications and compliance.

  • 📉 Statistical Data Analysis & Trend Monitoring: Conducted data-driven decision-making, utilizing SPC, DOE, and Six Sigma methodologies for quality improvements.

Cross-Functional Collaboration & Troubleshooting

  • 🔬 Cross-Functional Teamwork: Worked closely with R&D, manufacturing, and regulatory teams to optimize product release and quality assurance.

  • 🏥 Clinical Integration & Troubleshooting: Partnered with healthcare professionals to assess device performance and ensure regulatory compliance in clinical environments.

  • 🛠 On-Site Problem Solving: Addressed technical challenges during audits and product deployment, ensuring seamless operations in real-world laboratory settings.

  • 📊 Lean & Six Sigma Methodologies: Applied continuous improvement techniques to optimize manufacturing processes and reduce waste.

  • 🌍 Supplier Quality Management: Collaborated with vendors and external suppliers to maintain material and component compliance with quality standards.

  • 💬 Technical Documentation & Communication: Developed clear, concise, and regulatory-compliant reports, protocols, and quality documentation to support audits and product approvals.

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