Quality Control Inspector - T2

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

San Clemente, CA

Glaukos

<p>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</p> <p>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;device in September 2018 and iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;W in September 2020.</p> https://www.glaukos.com/

keywords: quality assurance,support,engineering,vision,process,environment,process management,compliance,quality assurance,analysis,support,medical,education,teamwork,organization,experience,communication

Full Time

Overview: <p><strong>How will you make an impact?</strong></p> <p>Based in San Clemente, the responsibilities of the Quality Control Inspector will include all aspects of inspection (receiving, in-process and final). In addition, this position will provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, label control, etc.</p>
Responsibilities: <p><strong>Receiving Inspection</strong></p> <ul> <li>Receiving inspection of components following procedures, specifications and drawings.</li> <li>Utilize a variety of standard metrology equipment, including: Optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, surface roughness testers, etc.</li> <li>Read engineering drawings and interpret geometric dimensioning and tolerancing.</li> <li>Review associated paperwork, complete inspection records using good documentation practices, and release components.</li> <li>Carefully handle and process extremely small components without damaging them.</li> </ul> <p><strong>In-Process Inspection</strong></p> <ul> <li>Work with engineering in the design of high quality inspection / metrology fixtures.</li> <li>Support equipment and process validation activities by inspecting process outputs.</li> <li>Conduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.</li> <li>Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.</li> <li>Coordinate the monthly environmental monitoring of the cleanrooms.</li> <li>Coordinate quarterly dose audits.</li> </ul>
Requirements: <p><strong>Education:</strong></p> <ul> <li>1-3 years industry experience.</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>Medical device experience and working knowledge of QSR a must.</li> <li>Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable.</li> <li>Attention to detail and accuracy a must.</li> <li>Must have excellent documentation skills.</li> <li>Team player, good written/oral communicator.</li> <li>Must be organized and able to coordinate activities with outside vendors.</li> </ul>