Provides oversight of the quality and efficacy of artificial intelligence algorithms and products. Ensures the quality system essentials are in place and that the AI Quality Plan is followed. Provides quality management training and education. Represents practice area in all regulatory inspections and oversees AI compliance quality documentation and validation programs. Performs internal audits, LEAN assessments, root cause analysis, error and trend analysis, etc. to identify opportunities for improvement. Bachelor's degree in computer science, informatics, quality management, industrial engineering or regulatory affairs from an accredited institution or bachelor's degree from an accredited institution. Four years of relevant experience with regulated Device or Software as a Medical Device (SaMD) or as a certified American Society for Quality Management or Society of Quality Assurance professional; or a Master's degree from an accredited institution in computer science, quality management, industrial engineering or regulatory affairs and two years of relevant experience with regulated Device or Software as a Medical Device (SaMD) or as a certified American Society for Quality Management or Society of Quality Assurance professional. In-depth experience of quality management concepts and regulatory/accreditation requirements. Experience with audit or inspection process. Self-motivated, highly organized, efficient, and ability to exercise strong decision making skills. Prior experience as a quality specialist is preferred. Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.
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