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Posted: Sunday, March 12, 2017 8:26 PM

The Quality Engineer III is responsible for leading Quality Engineering support for manufacturing, product design, product development, and process development. Lead and mentor in the development of verification and validation protocols. Addresses less common and moderately difficult problems with appropriate solutions. Initiates and leads process improvement efforts and applies statistical analysis, six sigma lean tools, and other tools and methods to critical business processes driving improvements across functional areas. Provides expert judgment and resolves complex process and quality issues. This role relies on experience and judgment to plan and accomplish goals and the ability to lead cross functional teams, and work in cross:functional teams to attain objectives.Each employeeA?s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows: Review new and modified product designs for quality characteristics, including quality, risk, product requirements.Responsible for leading and managing product and process verification, validation, protocol development and optimization/improvement activities.Ensure that product development projects and changes to existing products are conducted in compliance with the Myriad Quality Systems, CLIA, FDA, and other applicable regulations.Promotes the use of lean principles to process flows, quality improvements, lead: time, cycle time and cost reductions while improving on time deliveries.Create a risk management plan, perform and facilitate product and device hazard analysis, and risk assessment. Assess risks and provides alternatives by utilizing statistical tools.Develops measurement systems based on sound quality engineering and lean six sigma principlesApplies quality engineering tools and principles to product and process validation. Lead and assists in the planning and execution of verification and validation studies.Ensures sampling, test and validation protocols along with executed validation meet internal specification and regulatory requirements through collaboration with all affected areas.Review Design History Files and Technical Files for conformance to applicable requirementsCoach project teams while applying continuous improvement methods and tools.Supports the internal quality system and consults in the preparation of technical documents for review and submission to regulatory and accrediting agencies.Supporting documentation for the education and experience requirements are maintained in the employeeA?s personnel file.Meets minimum education and experience requirements:Minimum of a BachelorA?s degree in engineering, science, statistics, or equivalent experience plus 5+ years of hand on experienceMasterA?s degree in engineering, science, statistics or equivalent experience plus 3+ years of hand on experience.Current Certified Quality Engineer, or Six Sigma Black BeltKnowledgeable in ISO 14971 and 21CFR820 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.Myriad Genetics, Inc. (Nasdaq: MYGN) is a leading molecular diagnostic company making a difference in patientA?s lives through to discovery and commercialization of transformative molecular diagnostic products that assess a personA?s risk of developing disease, improve diagnosis, predict disease progression and guide therapy. We believe in improving the healthcare management of patients by providing physicians and patients w

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• Location: salt lake city

• Post ID: 11349892 saltlakecity
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