MAIN PURPOSE OF JOB:The primary purpose of this position is to perform standardized measurements of parts in-process involving prescribed measurement tools under guided supervision. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.MAIN JOB RESPONSIBILITIES: Primarily performs incoming or in-process inspection of raw materials and components for conformance to specifications such as dimensions, tolerances, and other purchase order requirements. May perform visual and functional in-process, and final inspection of devices or labels. Utilize mechanical and optical inspection equipment to measure components and devices to verify product meets specification.Utilize quality procedures, specifications, work instructions, and associated documents in the performance of inspection duties.Identify and process nonconforming material in accordance with established procedures.Provide quality assurance support within the organization as experience and time allow.Writing and preparing inspection reports regarding inspection and testing resultsOther duties may be assignedPOSITION REQUIREMENTS:Knowledge/Education:High School Diploma or equivalentExperienced in Microsoft office suites (excel, word, power point, outlook)Solid experience with quality systems documentsStrong organizational skills with proven ability to complete multiple tasks simultaneouslyStrong understanding of FDA CFR 820, ISO 13485Job Experience:Minimum 2 years of quality assurance experience or machine operations experience with in-process inspection exposure in a manufacturing environment required.Skills/Competencies:Ability to communicate and work with those inside and outside the department, handle multiple assignments and prioritize accordingly.Demonstrated attention to detailBasic understanding of blueprint reading, inspection equipment and sampling plansBasic machine shop math (fractions to decimals and metric conversion)Ability to follow appropriate department policies, procedures and practices. Positive teamwork attitude.Good problem solving skills.Good writing and verbal skills.Understanding of Lean Manufacturing philosophies Physical Requirements: Light work: Exerting up to 50 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.