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With a robust foundation in engineering (BS & MS in Mechanical Engineering, MS in BioMedical Engineering) and hands-on experience in Systems and Quality engineering, I specialize in bridging R&D, Operations, and Regulatory teams to deliver high-impact solutions. At Wondfo USA, I spearheaded the Development of Quality Assurance Systems for diagnostic devices, ensuring compliance with FDA and ISO 13485 standards, and optimized cross-functional workflows for product development and manufacturing. ๐๐ฆ๐บ ๐ด๐ต๐ณ๐ฆ๐ฏ๐จ๐ต๐ฉ๐ด: ๐ฝ๐๐-๐๐๐๐ฉ๐ช๐ง๐ ๐๐๐๐ฃ๐ ๐๐ฃ๐: Architect end-to-end solutions, balancing technical and operational trade-offs. ๐ฟ๐๐ฉ๐-๐ฟ๐ง๐๐ซ๐๐ฃ ๐๐ฃ๐จ๐๐๐๐ฉ๐จ: Leverage analytics to enhance efficiency and decision-making. ๐พ๐ค๐ก๐ก๐๐๐ค๐ง๐๐ฉ๐๐ค๐ฃ & ๐๐๐๐๐๐ง๐จ๐๐๐ฅ: Foster synergy across departments, driving projects to meet aggressive deadlines. ๐๐๐๐ช๐ก๐๐ฉ๐ค๐ง๐ฎ ๐๐ญ๐ฅ๐๐ง๐ฉ๐๐จ๐: Deep knowledge of FDA frameworks for medical devices, with a diploma in regulatory affairs. Passionate about technology, process optimization, and mentoring teams, I thrive in dynamic environments where I can solve complex challenges and deliver measurable results. Letโs connect to explore how I can contribute to your teamโs success!
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