Quality Control Inspector II - 2nd Shift

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p> <br /><br />Base Salary Range: $40,900 - $53,200

San Clemente, CA

Glaukos

<h4>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.</h4> <h4>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;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

keywords: position summary,compensation,performance,quality assurance,engineering,analysis,inspect,process,compliance,write,experience,skills,education

Full time

Base Salary Range: $40,900 - $53,200

Overview: The Quality Control Inspector II will be responsible for 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.
Responsibilities: <p>Receiving Inspection&nbsp;</p> <ul> <li>Receiving inspection of components following procedures, specifications and drawings.&nbsp;</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.&nbsp;</li> <li>Read engineering drawings and interpret geometric dimensioning and tolerancing.&nbsp;</li> <li>Review associated paperwork, complete inspection records using good documentation practices, and release components.&nbsp;</li> <li>Program the Smartscope to run automatic routines for multiple part inspections. (Level 2 and higher)&nbsp;</li> <li>Write clear and concise procedures for inspection of components, machined tubing, etc. (Level 2 and higher)&nbsp;</li> <li>Carefully handle and process extremely small components without damaging them.&nbsp;</li> </ul> <p>In-Process Inspection&nbsp;</p> <ul> <li>Perform Line Clearance for Operations activities&nbsp;</li> <li>Inspect and release labeling&nbsp;</li> <li>Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.&nbsp;</li> <li>Perform inspections on components and assemblies in manufacturing&nbsp;</li> </ul> <p>Final Inspection&nbsp;</p> <ul> <li>Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.&nbsp;</li> <li>Perform final inspection on finished goods&nbsp;</li> <li>Inspect finished goods for proper labels, packaging, tamper seals and product in accordance with procedures.&nbsp;</li> <li>Coordinate final inspection activities with outside vendors, i,e, LAL, peel testing&nbsp;</li> <li>Perform in-house peel testing on sealed packages&nbsp;</li> <li>Maintain sample retain area&nbsp;</li> </ul> <p>Other Duties&nbsp;</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&nbsp;</li> <li>Conduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.&nbsp;</li> <li>Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.&nbsp;</li> <li>Coordinate the monthly environmental monitoring of the cleanrooms.&nbsp;</li> <li>Coordinate quarterly dose audits.&nbsp;</li> </ul>
Requirements: <p>Experience</p> <ul> <li>College courses or degree preferred</li> <li>Level 2: &nbsp;3-7 years industry experience&nbsp;</li> </ul> <p>Knowledge, Skills, and Abilities</p> <ul> <li>Medical device experience and working knowledge of QSR a must&nbsp;</li> <li>Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable&nbsp;</li> <li>Attention to detail and accuracy a must&nbsp;</li> <li>Must have excellent documentation skills&nbsp;</li> <li>Team player, good written/oral communicator&nbsp;</li> <li>Must be organized and able to coordinate activities with outside vendors&nbsp;</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.</p> <p>Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover,&nbsp;Glaukos Corporation has been Certified as a Great Place to Work the last two years!</p> <p>Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.</p>