Principal Quality Engineer, Design Assurance

<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>

Aliso Viejo, 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/

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Full time

Overview: <p>The&nbsp;<strong>Principal Quality Engineer, Medical Device Design Assurance</strong>&nbsp;position will be based in Aliso Viejo, CA and will directly support the development of innovative ocular medical devices.</p> <p>This position will provide quality engineering support in design, development and commercialization of medical device and combination products.</p>
Responsibilities: <ol> <li>Provide quality engineering support in design, development and commercialization of medical device and combination products <ul> <li>Responsible for management of quality aspects of design controls and ensuring that there is clear traceability from design planning to commercialization.</li> <li>Ensure robust final product testing is designed, developed, and implemented.&nbsp;</li> <li>Review design history technical files for conformance to applicable requirements and regulatory standards. Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc.</li> <li>Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.</li> <li>Implement and support product reliability assessments.</li> </ul> </li> <li>Facilitate the application of design controls in product development and sustaining changes <ul> <li>Manage design control and master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, Test method validation.</li> <li>Review new or modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.</li> <li>Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues.</li> </ul> </li> <li>Post Market Surveillance &amp; Risk Management <ul> <li>Manage risk management process and post market feedback review and updates.</li> <li>Continuously improve the risk management process.</li> <li>Perform or support audits (internal, external, and by regulatory agencies) and risk-based supplier assessments.</li> <li>Provide product understanding and support during audits.</li> </ul> </li> </ol> <p>Other Duties as Assigned</p> <ul> <li>Additional other duties and projects as required to facilitate R&amp;D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.</li> </ul>
Requirements: <ul> <li>Bachelor&rsquo;s Degree in Engineering, Science or related field.</li> <li>12+ years of work experience in a production or engineering environment and 8+ years as an engineering technician work.</li> <li>5+ years of medical device experience required, 10+ years preferred.</li> <li>3+ years of leadership required, 5+ years preferred.</li> </ul> <p>Knowledge, Skills, and Abilities</p> <ul> <li>Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements.</li> <li>Strong knowledge of medical device manufacturing.</li> <li>Knowledge in sterilization and laboratory testing.</li> <li>ASQ certifications preferred. CQA, CBA, CQE</li> <li>Excellent documentation skills, 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>