Quality Assurance | Continuous Process Improvement
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A highly motivated and proactive Quality Assurance and Quality Control professional with a strong history of driving improvements and ensuring compliance within regulated manufacturing environments. Possessing a comprehensive understanding of GMP, ISO 9001:2015, IATF 16949:2016, and FDA regulations, I excel at collaborating with engineering teams to optimize processes and achieve critical quality targets. My expertise lies in implementing root cause analysis, continuous improvement initiatives, and training programs, consistently contributing to reduced defects, increased efficiency, and enhanced product quality.
I am adept at leveraging data analysis and quality management systems to ensure adherence to the highest standards.
A seasoned Quality Assurance and Quality Control professional with a consistent history of contract roles across regulated industries, including medical devices and pharmaceuticals, demonstrating expertise in GMP, FDA regulations, ISO standards, and continuous improvement methodologies. Throughout various positions at companies like EATON, Beiersdorf, and Bayer, I've spearheaded process improvements, conducted in-depth data analysis, ensured regulatory compliance, provided quality training, and implemented root cause analysis to enhance product quality, reduce non-conformances, and drive operational efficiency. My experience showcases a proactive approach to quality management, a strong understanding of quality systems, and a commitment to maintaining high standards across the manufacturing lifecycle.
Holding a Bachelor of Science in Business Administration with a minor in Business Information Systems from DeVry University, complemented by certifications in ISO 9001:2015 and ISO 14001 Internal Auditor Training, provides a strong foundation in business principles and quality management systems.
