Quality Engineer I, Validations

<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>

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: about glaukos,review,plan,duties,education,experience,qualifications

Full time

Overview: <h2 class="job-details__description-header text-color-secondary font-family-secondary" data-bind="i18n: 'job-details.employer-description-title'">ABOUT US</h2> <div class="basic-formatter" data-bind="html: job().corporateDescription"> <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> <p>&nbsp;</p> </div>
Responsibilities: <ul> <li>Provide technical expertise in the review and approval of qualification activities for GMP manufacturing facility, supporting utilities, calibration, metrology activities and documentation</li> <li>Author and execute IOQ, PQ validation protocols and reports for equipment, facility, utilities.</li> <li>Author, review, revise Quality SOPs</li> <li>Review qualification and validation activities and generate the associated documentation (reports, calibration certificates, drawings and etc.).</li> <li>Prioritize, plan, and execute work activities in alignment with department and company priorities with minimal supervision.&nbsp;</li> </ul>
Requirements: <ul> <li>Bachelor&rsquo;s degree in a Biology, Chemistry, or Engineering field.&nbsp; ASQ certifications CQE, and similar certifications are desirable.&nbsp;</li> <li>2+ years of experience in Pharmaceuticals, Biologics, combination products in areas of Quality Assurance, Validation, Engineering support</li> <li>Familiarity with 21 CFR Part 210/211, ICH Q7, Q9, Q10, WHO, EU applicable regulatory guidance.</li> <li>Must be organized and able to coordinate activities with internal departments/ outside vendors</li> <li>Ability to effectively negotiate and build collaboration, team player</li> <li>Proficient in computer skills (e.g. Word, Excel, Power Point, Visio)</li> <li>Self-motivated, detail-oriented, must demonstrate attention to detail and accuracy</li> <li>Good written/oral communication</li> </ul>