Quality Control Inspector

Quality Control Inspector - Medical Device Company

Job Description: QUALITY CONTROL TESTER MEDICAL DEVICE CATHETERS - $18-$22 Position Overview Supports the implementation and maintenance of a quality management system infrastructure. Supports device manufacturing. Supports design and development for a variety of medical device technologies. Maintains compliance within a regulated environment (i.e. CFR, MDD, PAL). JOB FUNCTIONS Performs the incoming inspection/test of materials, components, tooling, packaging, and labeling as well as the work-in-process inspection/test of subassembly and finished devices. Inspects in accordance with established sampling plans and acceptance criteria Inspects in accordance with established blue-print and drawing specifications Performs First Article inspections as appropriate Performs manufacturing workstation audits as appropriate Initiates rejection reports for non-conforming materials, components, tooling, packaging, and labeling as well as the work-in-process inspection/test of subassembly and finished devices. Tests prototype/qualification/validation materials, components, tooling, packaging, and labeling as well as subassembly and finished devices. Organizes and maintains inspection areas and associated documentation (files and test records) ESSENTIAL REQUIREMENTS 2-5 years experience with class II/III medical device RD, Manufacturing, and/or Quality. Attention to detail and working knowledge of precision measuring equipment and associated techniques (precision calipers, micrometers, pin-gauges, microscopes, and related equipment). Computer skills (MS Word, Excel, PowerPoint and so on). Good writing skills (must be able to demonstrate) and penmanship. Good communication skills, team player, and ability to prioritize work Working knowledge of inspection plans/statistical sampling techniques (C=0; ANSI/ASQ Z1.4;ANSI/ASQ Z1.9; reduced, normal, and tightened switching rules; single; double; and so on). OTHER REQUIREMENTS Inspection certificate/s, Workmanship standards certificate/s, and specialized training in inspection techniques and related functions. Experience with balloon catheters, guide wires, stents, and stent delivery systems is preferred. We are an equal employment opportunity employer. You can view all of our jobs online at http://www.appleone.com/?sc=11id=665938