David Kongo Email & Phone Number

I am an expert Certified Quality Engineer (CQE). My abilities extend to meticulous processes such as medical device validation, employing methods such as FMEA to ensure robust product performance. My proficiency in plastics injection molding encompasses the creation and implementation of validation protocols, along with thorough process and mold validations. With automated assembly, I excel in crafting validation protocols and conducting comprehensive machine validations. I am adept in Advanced Quality Planning where I ensure meticulous preparation and execution throughout every stage. Additionally, I possess extensive experience in ISO auditing, including ISO 13485 standards, and adeptly conduct supplier auditing to maintain exceptional quality standards. Adhering to FDA Quality System Regulations (QSR), I navigate regulatory compliance seamlessly, facilitating smooth transitions for new product introductions. My utilization of statistical methodologies further enhances my capabilities, enabling precise analysis and optimization at every juncture.

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  University Of Massachusetts Amherst

  Industrial Engineering And Operations Reasearch