Quality Control Inspector (2nd shift) 1:30pm-10:00pm

Job Type Full-timeDescriptionThe Quality Inspector performs inspections, checks, tests, sampling procedures, and lot release of incoming materials, subassemblies, finished goods, parts, and components used in the manufacture of dental aligner medical devices. RequirementsRESPONSIBILITIES:•Performs inspections of purchased parts according to material specifications. •Performs in-process inspections of dental aligner, retainer, and attachment products per MPI and LHR quality review criteria.•Initiates NCMR reports on nonconforming material.•Accurately documents the results of inspections and testing on LHRs and inspection records.•Performs final release of product per LHRs and distribution records review and approval.•Maintains all controlled document files and inspection records in a timely and accurate manner.•Coordinates calibration of equipment and fixtures using approved metrology services, as required. •Monitors critical equipment and instrumentation to ensure proper calibration. •Participates in the creation and/or revision of SOPs for the inspection function. •Assists in writing and updating inspection procedures, protocols, and checklists. •Evaluates quality/quality system problems and make initial recommendations for possible corrective action to supervisor. •Conducts and document process and system audits using written procedures as audit standards. •Utilizes computer for obtaining and data entering information.•Provides support to Manufacturing when required.•Manages quarantine inventory.EDUCATION /EXPERIENCE REQUIREMENTS•High School diploma or GED required.BASIC REQUIREMENTs•Minimum one (1) year of experience in Quality Control or medical device manufacturing. •Knowledgeable and proficient in Microsoft Office products (especially Word & Outlook).•Familiarity and ability to follow documented instructions per SOP's, MPIs, LHRs & standards.•Knowledge of ISO Quality Standards (ISO 9000 or ISO 13485), FDA, & QSR.•Familiarity with ANSI Z1.4 and Sampling Procedures and Tables for Inspection by Attributes (AQL).POSITION REQUIREMENTS •Must be a team player and constantly keep the results of the business top of mind.•Ability to read, write and interpret information.•Must be flexible for different shift hours of operation as required.•Can follow policies and procedures and adjust to changes when needed.•Must be able to sit/walk/stand for the full shift.•Must possess visual acuity, i.e., close, distance, and color vision, depth perception and the ability to adjust focus.•Ability to lift/carry items less than 25 pounds.•Must be computer literate and comfortable with operating and navigating program menus and tasks.