Sr. Supplier Quality Engineer I

<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: quality assurance,performance,analysis,assessment,submit,communication,execute,maintenance,support,communication,knowledge,teamwork,degree,experience,certification

Full time

Overview: The Sr. Supplier Quality Engineer will support the development and manufacturing of Class III medical devices. This person has primary responsibility in execution of the supplier quality program.
Responsibilities: <ul> <li>Review and approve&nbsp;requests for new suppliers</li> <li>Determine classification and risk level for new suppliers as well as establish qualification requirements.</li> <li>Perform technical supplier assessments while initiating&nbsp;quality agreements for new suppliers</li> <li>Execute&nbsp;supplier qualification activities and establish&nbsp;necessary controls while executing supplier part qualification activities</li> <li>Maintain&nbsp;sourcing control between parts and suppliers</li> <li>Submit&nbsp;and review changes to supplier classification, supplier risk level and supplier status</li> <li>Take&nbsp;necessary actions, including issuing Supplier Corrective Action Requests) to improve supplier performance, as needed</li> <li>Support&nbsp;maintenance of the Supplier Quality Records</li> <li>Supplier Assessment schedule development and execution, including performing supplier audits</li> <li>Update supplier profiles or documentation as needed related to supplier changes</li> </ul>
Requirements: <ul> <li>Bachelor&rsquo;s Degree in Engineering, Science or related field</li> <li>4 to 8 years relevant work experience in a medical device manufacturing work environment in a quality discipline.</li> <li>Working understanding of 21 CFR Part 820, ISO 13845 and ISO 14971 requirements</li> <li>Strong knowledge of medical device manufacturing</li> <li>ASQ certifications preferred. CQA, CBA, CQE</li> <li>Strong documentation skills, attention to detail and accuracy</li> <li>Strong written/oral communication skills</li> <li>Ability to work cooperatively and effectively in a team environment.</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong></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! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!</p>