Qualified Quality Engineer accustomed to developing and monitoring improved inspection strategy to reduce errors and cultivate consistent quality. Dedicated and energetic with proven history of implementing corrective actions to drive quality and improve efficiency. Detail-oriented and motivated Quality Engineer with 4 years of extensive experience in the medical device industry, focused on product quality, regulatory compliance, and continuous improvement initiatives. Proficient in managing CAPA processes, conducting thorough root cause analysis, and ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. Experienced in working with orthopedic implants, diagnostic devices, and women’s health products, ensuring product safety and quality across all stages of production. Adept at managing non-conformance issues and driving supplier quality improvements through SCAR initiatives. Seeking to apply a strong technical and analytical skill set to contribute to a dynamic quality assurance team in a regulated manufacturing environment.