Quality Systems Engineer

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

San Clemente, CA

Glaukos

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. <br /><br />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.<br /><br />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. https://www.glaukos.com/

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Full time

Overview: Located in Burlington, MA, we have an exciting opportunity for a Quality Systems Engineer at a dynamic company with a hybrid work schedule. The individual in this role will implement, manage, update&nbsp;and&nbsp;administer QMS systems to ensure they meet quality and regulatory requirements. They will be involved in the development and/or review of validation plans, protocols, reports and SOP&rsquo;s as needed. In addition, it will be necessary to troubleshoot system issues and coordinate work across multiple software platforms (e.g., 123 Compliance, Oracle, Helix, Audit Board, and SalesForce) as well as have an understanding of all applicable Standards and Regulations including but are not limited to FDA 21CFR Parts 11, 820, 58, 210, 211, ISO 13485, IEC 62304, Health Canada, E.U.
Responsibilities: <ul><li>Provide risk-based approach to ensure computerized systems meets GxP Quality standards and regulatory requirements.</li><li>This role will provide oversight for GxP software quality and validation activities and the enforcement of applicable standard operating procedures.</li><li>Manages updates to Quality Systems including upgrades, adding/removing users and modifying user profiles.</li><li>Develop and/or review updates planned for current QMS software.</li><li>Develop and/or review software validation plans, IQ/OQ/PQ protocols and reports; Standard Operating Procedures; Requirements Traceability Matrix etc.</li><li>Develops and/or configures Quality systems module content such as drop-down fields, field changes, process flows, etc.</li><li>Conduct(s) failure investigations in coordination with the vendor/partners to determine and resolve system functionality problems.</li><li>Troubleshooting system issues and generally ensures the assigned software can be used as intended. This may include creating functional documentation, reports, training materials and provide training to staff within their area of expertise.</li><li>Developing and delivering relevant training material regarding GxP related systems, including compliance training on relevant regulatory requirements.</li><li>Coordinating and working with multiple software platforms (e.g., 123 Compliance, Oracle, Helix, Audit Board, and SalesForce) to trouble-shoot application issues.</li><li>Consistently maintaining an understanding of all applicable Standards and Regulations as they apply to the Company (these include but are not limited to FDA 21CFR Parts 11, 820, 58, 210, 211, ISO 13485, IEC 62304, Health Canada, E.U.).</li><li>Responsible for creating and/or revising applicable QA procedures (SOPs, Work Instructions, etc.) so that they comply with current and applicable regulations.</li><li>Responsible for other duties and projects as assigned. </li></ul>
Requirements: <p>Education:​​​​​​​</p> <ul> <li>Bachelor&rsquo;s degree in Computer Science or other related fields.</li> </ul> <p>Requirements:</p> <ul> <li>2-5 years of experience as an analyst/administrator for an electronic data management system.</li> <li>Prior experience in an FDA-regulated industry, such as pharmaceutical, biologic or medical device preferred.</li> <li>2-5 years of experience in the areas of software validation.</li> <li>Understanding of &nbsp;IT Quality/Compliance, 21CFR Part 11 compliance, general data and access security of applications, disaster recovery for IT cloud-based and server-based applications.</li> <li>Excellent communication, problem solving, organizational and interpersonal skills are required.</li> <li>Strong project management skills preferred.</li> </ul>