Document Control Coordinator II

<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,document,support,duties,reporting,qualifications,experience,degree

Full time

Quality

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.<br /><br /></p> <p><strong>Glaukos &ndash; Document Control Coordinator II</strong></p> <p><strong>How will you make an impact?</strong></p> <p>This position is responsible for ensuring the document control and training systems are maintained and functioning in compliance with Glaukos procedures and external standards and regulations. In addition to QA responsibilities, there will be other activities required that support Production and Product Development as needed.</p>
Responsibilities: <p>Document Control</p> <ul> <li>Administering the&nbsp; CATSWeb Document&nbsp; Control database.</li> <li>Provide support to&nbsp; all personnel for document&nbsp; &nbsp;control</li> <li>Creating reports in the CATSWeb system for Management Review, Trending requests,&nbsp;&nbsp;e&nbsp;t&nbsp;c .</li> <li>Maintaining the document control and training modules within the&nbsp;CATSWeb system</li> <li>Addressing quality system gaps within the document control system stemming from audits.</li> </ul> <p>Training</p> <ul> <li style="list-style-type: none;"> <ul> <li>Administering the CATSWeb Training database.</li> <li>Provide support to all personnel for&nbsp;training</li> <li>Monitor the status of the training&nbsp;process</li> <li>Provide reports on the status of&nbsp;training</li> <li>Coordinate group training when needed&nbsp;Design History Files <ul> <li>Working with project managers on compiling and maintaining&nbsp;the DHFs.</li> </ul> </li> </ul> </li> </ul> Other Duties<br /> <ul> <li>Other duties as assigned</li> </ul>
Requirements: <ul> <li>Bachelors degree, preferably in a Science</li> <li>Level 2: 3-8 years industry experience</li> <li>Must have excellent documentation skills</li> <li>Attention to detail and accuracy a&nbsp;must</li> <li>Medical device experience and working knowledge of QSR</li> <li>Medical device complaint experience preferred</li> <li>Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable</li> <li>Team player, good written/oral communicator</li> <li>Able to thrive in a small, entrepreneurial environment</li> <li>Must be organized and able to coordinate activities with internal departments and outside vendors</li> </ul>