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Company Overview OrthoPro, The Foot and Ankle Company, was developed in 2003 with the help of several Podiatrists and Orthopedic foot & ankle surgeons. The company was created to focus specifically on the advancement of products for the lower extremities. OrthoPro is Dedicated to Providing Quality and Innovative Foot and Ankle Products. The company is located near the base of the Wasatch Mountains in Salt Lake City, Utah. Job Title Quality Inspector (QI) Job Description This position will be primarily responsible for performing incoming, in-process, and final inspection of products. The position requires packaging and/or processing of sterile and non-sterile products. In addition, the position will assist with filling sales orders, supporting new product development, assisting with sustaining quality activities, and for ensuring continuing compliance to regulatory (FDA/ISO/ANVISA/etc.) requirements. The QI position will report directly to the Quality Manager. Essential Functions -Ability to read, interpret, and follow procedures and work instructions -Ability to read and interpret CAD drawings -Possess Basic knowledge of acceptance sampling, basic statistical/probability theory, and c=0 sampling -Working knowledge of (GD&T), ASME Y14.5 certified preferred -Performs and documents inspection and packaging of product -Visual Inspection with and without magnification -Verify that logs and/or forms are documented correctly -Accurately initiate and document nonconforming products -Support the creation and implementation of the quality system based on ISO 13485 and FDA regulatory guidelines -Assist the operations department (product processing) as necessary
Relocation costs may be covered.
Minimum Requirements -Must have 1-3 years of work experience in medical device quality control-preferably orthopedic experience -Must have experience using standard inspection tools, equipment, and standard sampling plans -Must work well with others and work effectively as a team member as well as follow directions from superiors -Strong interpersonal and organizational skills and attention to detail is essential - Working knowledge of FDA quality system regulations and ISO standards -Possess the ability to make independent decisions and/or recommendations -CQI certification through ASQ preferred Education High School Diploma Mandatory Associates or equivalent preferred Benefits Competitive Salary-commensurate with experience Health Insurance, Health Savings Account (HSA)-with employer matching, and paid vacation Please email your resume to firstname.lastname@example.org if you are interested in this position.