Quality Assurance Engineer (Medical Device)
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I'm Alex Sasi, pursued my bachelor of engineering in Electrical and Electronics. I have overall 4+ years of experience into the Medical Device industry working as Quality Assurance Engineer.
Quality Assurance Engineer with 4.2 years of experience in the medical device industry, specializing in QMS and regulatory compliance. Experienced in verification and validation, E-QMS implementation (ISO 13485/21 CFR Part 820), and regulatory submissions, including Q-submission and 510(k). Previously worked in quality control and production engineering roles, contributing to product development, process optimization, and compliance.
Certified ISO 13485 Internal Auditor, Lean Six Sigma Yellow Belt, and trained in MDR 2017/745 fundamentals and SCRUM methodologies. Passionate about advancing medical technology and quality standards.
Bachelor of Engineering in Electrical and Electronics Engineering
