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Job #03450

About our client Our client is a rapidly expanding medical device firm headquartered in Utah that specializes in diagnostic/surveillance devices used in genetic and pathogen identification. The organization has an experienced management team, a world-class corporate culture and an established reputation for being a leading innovator in the field. Position Location Director of Quality Assurance Salt Lake City, Utah Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle all aspects of the development, implementation and maintenance of a company wide quality system (flexible and streamlined but in compliance with the FDA QSR) 2) Manage and direct the company's efforts towards obtaining FDA approval for selected medical devices and in vitro diagnostics (IVD) 3) Perform all work in compliance with company policy and within the company's quality system 4) Ensure quality for all products and they meet the requirements of the FDAs QSR for medical devices (21 CFR 820) for the development and manufacturing of selected products 5) Direct and manage the company's efforts towards obtaining FDA approval for selected medical devices (instruments and software) as well as reagents (IVDs) 6) Serve as a spokesperson for the company on issues related to quality assurance and regulatory affairs 7) Implement a safety program that is compliant with applicable regulations Requirements 1) Bachelor's degree in a scientific or related field 2) Minimum 3 years of leadership experience in quality/regulatory assurance 3) Minimum 3 years of medical device experience 4) Experience in IVDs (reagents) (preferred) 5) Strong understanding of FDA/CFR regulations and guidelines