Quality Engineer II, Operations

<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>

Burlington, MA

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,training,assist,other duties,review,duties,experience,qualifications,education

Full time

Overview: <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> <p>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.</p> <p>Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol &ldquo;GKOS&rdquo;. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.</p>
Responsibilities: <p>What Would You Do?</p> <ul> <li>Primary responsibilities include working in&nbsp;Quality Operations, Quality Engineering and with other functional groups in support of day-to-day activities relating to legacy products.</li> <li>Calibration Management utilizing Maximo Software</li> <li>Nonconformance Management utilizing Trackwise.</li> <li>Reviewing Incoming Inspection Records, Travelers and DHR&rsquo;s for the acceptance of raw materials, WIP and Finished goods.</li> <li>Review and revise quality control plans</li> <li>Execute equipment qualifications (gage R&amp;R studies, etc., document change orders.</li> <li>Develop and manage metrology equipment requirements, maintenance, and validation.</li> <li>Provides technical assistance/oversight in defining and conducting both internal and external product and process audits, working closely with Quality Operations, Product Development, and Manufacturing personnel as well as vendors.</li> <li>Ensure compliance with all Federal, State, local and company regulations, policies, and procedures.</li> <li>Performs other quality-related duties as assigned by supervisor.</li> <li>Initiate and investigate component, process, and Product NCRs</li> <li>Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.</li> <li>Assist in complaint analysis as appropriate.</li> <li>Train, coach, and guide lower-level employees on routine procedures.</li> <li> <p>Initiate and investigate component, process, and Product NCRs</p> </li> <li> <p>Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.</p> </li> </ul> <p>&nbsp;</p> <ul> <li>Assist in complaint analysis as appropriate.</li> </ul> <ul> <li>Train, coach, and guide lower-level employees on routine procedures.</li> <li>Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations.</li> <li>Performs other duties assigned as needed.</li> </ul>
Requirements: <p>How Will We Get There?</p> <ul> <li>Bachelor&rsquo;s Degree in a technical field, preferably engineering or life sciences &nbsp;&nbsp;</li> <li>3-7 years of quality engineering experience in a regulated industry (medical device, pharmaceutical, aerospace, automotive)</li> <li>Knowledge, Skills, and Abilities</li> <li>Strong knowledge of medical device manufacturing</li> <li>Working understanding of GMP and ISO 13845 requirements</li> <li>A work style of hands-on involvement with all phases of projects</li> <li>Experience performing in-process assembly and manufacturing verification inspections desirable</li> <li>Excellent documentation skills with attention to detail and accuracy</li> <li>Team player, good written/oral communicator</li> <li>Must be organized and able to coordinate activities with internal departments and outside vendors</li> </ul>