Aidous Ngwe

Quality/ Failure Analysis Engineer with 6 years of experience in failure investigation, root cause analysis, and CAPA management within GMP-regulated manufacturing environments. Skilled in leading cross-functional investigations, enhancing QMS protocols, and ensuring compliance with GxP, ISO 9001:2015, and FDA regulations to improve product reliability and safety. My experience at Amgen, Abbott laid a perfect foundation for me to support and improve productivity.

Failure Analysis Engineer - Insulet Corporation

(2026-06)

• Conducted comprehensive failure analysis on returned products, manufacturing defects, and field failures using analytical techniques such as microscopy, X-ray imaging, electrical testing, and cross-sectional analysis to determine root causes.
• Led cross-functional root cause investigations by collaborating with Manufacturing, Quality, R&D, Supplier Quality, and Process Engineering teams to implement effective corrective and preventive actions (CAPA) that reduced recurring product failures.
• Authored detailed technical failure analysis reports, documenting investigation methods, findings, root causes, risk assessments, and engineering recommendations while ensuring compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices (GDP).
• Analyzed reliability, manufacturing, and customer complaint data using statistical methods and trend analysis to identify failure patterns, improve product reliability, and support continuous process improvement initiatives.
• Supported product development and manufacturing by validating corrective actions, evaluating design and process changes, and providing technical expertise during nonconformance investigations, design verification activities, and engineering change implementations.

Senior Quality Assurance Associate - Amgen

(2023-10 - 2026-02)

• Worked on comprehensive failure investigations for GxP deviations and product complaints
• Executed and tracked workflows for creation, revision, and obsoletion of documents with the controlled document management system (CDOCS).
• Assisted in the implementation of corrective and preventive action plans within specified timeframes to address root causes of non-conformances
• Collaborated with cross-functional teams to facilitate actions and ensure compliance with change controls, CAPA, deviations, and complaints, while diligently following up on internal GxP audit observations
• Supported inspections and audits by retrieving and compiling requested documents on the manufacturing controlled and non controlled classified areas of production
• Worked on the maintenance and enhancement of existing quality processes to ensure continuous compliance and operational effectiveness of quality systems
• Updated, maintained, and enhanced quality management system process documents and related documentation
• Analyzed data, prepared quality trend metrics, and reported results to internal stakeholders
• Conducted Product Quality Reviews (PQRs) in accordance with requirements
• Developed and maintained detailed product specifications
• Reviewed and approved Equipment User Records (EURs), Manufacturing Attachments, and Electronic Batch Records (EBRs)
• Conducted Manufacturing Quality Oversight and Focus Process walkthroughs
• Executed and documented comprehensive root cause analyses using quality tools and techniques to systematically evaluate and resolve quality issues, promoting continuous improvement
• Applied structured root cause analysis methods, including 5 Whys and Fishbone diagrams, to identify underlying issues
• Investigated GxP non-compliances and customer product quality complaints thoroughly
• Analyzed and initiated deviations addressing product or production malfunctions

Quality Engineer - Abbott Diagnostics

(2022-01 - 2023-08)

• Managed a contract focused on the production of BinaxNow Covid-19 Test kits, ensuring delivery against project expectations.
• Investigated production failures and implemented corrective actions.
• Diagnosed manufacturing defects and improved product quality.
• Used CAPA and FRP systems to prevent recurring failures.
• Performed failure trend analysis across production cycles.
• Conducted audits to ensure compliance with ISO 9001:2015 requirements, reinforcing quality standards across operations.
• Diligently implemented QMS policies to enhance customer satisfaction and support company growth initiatives.
• Designed and executed QMS policies while employing the Plan-Do-Check-Act (PDCA) cycle to foster ongoing product quality improvements.
• Defined quality metrics for all manufacturing procedures to ensure compliance and efficacy, driving continuous progress.
• Monitored the complete production cycle and promptly addressed any identified malfunctions, enhancing operational integrity.
• Established comprehensive guidelines outlining necessary checks and quality standards for processes, improving workflow clarity.
• Updated the Quality Management System (QMS) with incidents, fixes, and improvements as they arose, maintaining current best practices.
• Conducted rigorous inspections of products or materials, examining for defects and durability issues.
• Diagnosed root causes of technical issues and recommended effective resolutions, optimizing production efficiency.
• Compiled detailed reports on malfunctions and corrective actions utilizing CAPA processes, enhancing documentation accuracy.
• Reviewed and analyzed current blueprints and quality documentation to verify compliance with established standards.
• Set and monitored quality assurance goals, adhering strictly to GMP guidelines stipulated by the FDA, vital for regulatory compliance.
• Reviewed batch records to ensure compliance with GDP guidelines, significantly enhancing the overall quality assurance efforts.
• Contributed to the company's leadership initiative, positively impacting production across various departments by promoting teamwork and operational excellence.
• Utilized CAPA processes to track, identify, and eliminate production malfunctions, leveraging the Failure Reaction Plan (FRP) to document and prevent future errors.

Quality Assurance Associate - Jabil Healthcare

(2020-01 - 2021-12)

• Monitored operations to ensure adherence to established production standards, maintaining product consistency.
• Investigated production defects and supported RCA activities.
• Applied CAPA processes to reduce recurring failures.
• Performed inspections to detect early failure indicators.
• Organized and archived Quality Management System (QMS) documentation for efficient access, enhancing retrieval processes.
• Labeled, sorted, and categorized documents to improve accessibility, thereby streamlining operations.
• Ensured consistency in documentation practices throughout the organization, reinforcing quality compliance.
• Implemented ISO 9001:2015, the leading standard for quality management systems, ensuring alignment with global best practices and improving operational quality.
• Diligently executed QMS policies to enhance customer satisfaction and facilitate company growth.
• Developed QMS protocols and instituted the Plan-Do-Check-Act (PDCA) methodology to support continuous product quality improvement efforts.
• Applied CAPA (Corrective and Preventive Action) processes to investigate and report underlying causes of production issues, driving corrective measures.
• Recommended adjustments to assembly and production processes to enhance operational efficiency.
• Inspected, tested, and measured materials or products for defects and durability concerns, safeguarding product integrity.
• Strictly adhered to GMP (Good Manufacturing Practices) standards to ensure product safety and quality, fostering compliance culture.
• Minimized inherent risks to product quality throughout the production and distribution cycle by implementing preventive measures.
• Ensured compliance with specifications by maintaining clean manufacturing facilities and defining, validating, and controlling manufacturing processes.
• Ensured that written instructions and procedures were clear and unambiguous, facilitating compliance and operational ease.
• Documented records during manufacturing and quality control to demonstrate adherence to defined procedures and protocols, reinforcing accountability.
• Followed PPE (Personal Protective Equipment) manufacturing guidelines meticulously to ensure workplace safety.

Bachelor of Science - Computer Science - University of Buea Cameroon (2012-12)