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Corrective and Preventive Action (CAPA) investigations

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Chunyi Chu

Project Timeline

Aug 2026 - Dec-2026

OVERVIEW

I supported a Corrective and Preventive Action (CAPA) investigation within a regulated medical device quality system, addressing a product performance issue that required structured root-cause analysis and cross-functional coordination. The objective was to identify underlying causes, implement effective corrective actions, and ensure long-term reliability while maintaining full documentation and traceability. My role involved analyzing test data, reviewing failure trends, and contributing technical insight to the investigation process. Working closely with engineering, manufacturing, and quality teams, I helped evaluate evidence, challenge assumptions, and ensure that corrective actions addressed root causes rather than symptoms. I supported verification of corrective actions using test results and assisted with documentation to justify technical decisions within the quality system. This work contributed to improved product performance and reinforced the importance of evidence-based decision making, clear communication, and disciplined problem solving in a regulated environment.

HighlightS

SKILLS

Root cause analysis and structured problem-solvingAnalyzing test data to support engineering decisionsUnderstanding of quality systems and regulatory expectationsCross-functional collaborationTechnical documentation and traceabilityRisk-based decision making
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Chunyi Chu

Mechanical Engineering Student

I am a Mechanical Engineering undergraduate with hands-on experience in regulated medical device development, test engineering, and design verification. I am especially drawn to hands-on engineering work that involves building, testing, and refining systems in environments where precision and reliability are critical.

My interest in engineering started early. In middle school, I began building and repairing computers — diagnosing hardware failures, swapping components, and learning how systems interact at both a physical and logical level. That curiosity naturally expanded into a broader interest in how complex systems are designed, tested, and improved.

Outside of academics and work, I am a car enthusiast who enjoys understanding vehicles beyond the surface level  from performance engineering to mechanical design decisions. This hands-on mindset carries into my engineering work: I enjoy building things, breaking them, understanding why they fail, and making them better. Looking ahead, I want to continue developing my skills within the biomedical device industry while exploring opportunities to apply engineering principles in the automotive space as well.

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