Quality Inspector
Resolve Surgical Technologies - marquette, MI
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Resolve Surgical Technologies is looking or a part-time Quality Inspector to join our team. Great opportunity for students looking for employment around a class schedule, or those looking for part-time hours. Resolve Surgical Technologies is a global, world-class CDMO+ that provides new product design, development, manufacturing, quality, and regulatory services in support of leading medical technology companies. Located near Lake Superior, in beautiful Marquette, Michigan, this "must-see" travel destination is truly an outdoor paradise, teeming with natural beauty year-round. With a community that is as beautiful as its shorelines, Marquette is an up and coming city that welcomes all styles of outdoor enthusiasts. POSITION SUMMARY: Support production operations working to achieve optimal product quality. Perform investigations for product nonconformance(s)/process noncompliance issues and document exception in the CAPA system appropriately. Assist in performing, documenting, and training personnel for proper use of quality equipment in production. Operate inspection equipment including but not limited to Vision Systems, CMM, profilometer, etc. Perform inspection activities for both purchased and in-house manufactured semi-finished and finished goods for conformance to specification, drawing, and inspection requirements using various visual, physical, mechanical, and/or electrical evaluations. Perform product acceptance testing, quality inspections, and data entry/data corrections. Accurately document results of inspections and testing, including nonconformance reporting when required. Perform review of documentation for compliance to established procedures and GDP. Ensure all non-compliance issues associated with inspections are accurately reported. Perform routine AQL inspections and conduct 100% inspections as required. Sample, analyze, and monitor product quality in accordance with established procedures. Effectively communicate issues to Quality Engineering and/or operations. Perform documentation activities that adhere to cGMP and GDP. Utilize various measurement tools and instruments such as calipers, scales, thickness gauges, force gauges, optical comparator, various hard gages, pipets, and other systems. Perform inspection activities of printed materials against master documents for differences. Update release status of materials electronically to indicate acceptance or rejection, and communicate status to various departments. Perform programming of inspection equipment (i.e. Vision Systems and Digital Comparators). Support Gage R&R's Conduct Bioburden Endotoxin Testing *This is not an exhaustive list of duties or functions and may not necessarily comprise all the essential functions* EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately) Quality Inspector I: High School diploma One year experience in medical device or Quality Control environment preferred 6+ months of relevant coursework preferred
Created: 2024-10-24