Supervisor, Quality Assurance, 2nd Shift

<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: The&nbsp;<strong>Supervisor, Quality Assurance</strong>&nbsp;is based in San Clemente, CA and will provide operational support and conduct activities to improve and assure manufacturing of Class III medical devices. This individual will work with cross functional department to resolve product quality (mainly production) issues. The Quality Supervisor will ensure all procedures and records meet regulatory and Glaukos requirements.
Responsibilities: <p><strong>Operation Support (Clean room and Final Packing):</strong></p> <ul> <li>Manage the daily activities of the department personnel and coordinate activities to meet production demand.</li> <li>Ensures that testing standards, procedures, and equipment provide reliable results and prevent shipment of off quality products</li> <li>Support production leads and operators for interpretation and methods following set standards.</li> <li>Monitors production activities to ensure compliance to internal procedures.</li> <li>Establish priorities and ensure maximum usage of assigned resources</li> <li>Conduct meetings regularly with inspectors and audit team to help consistency in teamwork (eg. DHR meeting GDP requirements).</li> <li>Involve in team driven actions to help improvements</li> <li>Compiles data and provides reports to monitor health of production.</li> <li>Develop new methods to resolve problems occurring during QA activities.</li> <li>Training staff as needed to properly complete QA documents and functions.</li> <li>Collaborate with manufacturing and engineering in the identification and resolution of quality issue.</li> <li>Investigates and dispositions nonconforming of issue identified during production.</li> <li>Initiate and investigate NCR and CAPA as appropriate.</li> <li>Assist, mentor, and guide inspectors as needed to achieve program goals.</li> <li>Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.</li> </ul> <p><strong>Quality System Maintenance:</strong></p> <ul> <li>Review supporting documentation for component and process changes at suppliers and component drawings and specification at Glaukos.</li> <li>Monitor and ensure procedures for productions are being adhered to and in compliance with regulations.</li> <li>Supports the Quality System, including the NCR process, CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions.</li> <li>Supports internal and external audits.</li> <li>Lead process improvements in the area of production including corrective and preventive actions and responding to audit findings.</li> </ul>
Requirements: <p><strong>Education:</strong></p> <ul> <li>To be successful in this role, you will need to have a minimum of 3 years + Masters' or 5 years&nbsp; + Bachelor of engineering experience.&nbsp;</li> </ul> <p><strong>&nbsp;Requirements:</strong></p> <ul> <li>Knowledge of medical device manufacturing.</li> <li>Working understanding of GDP, GMP and ISO 13485 requirements.</li> <li>Working knowledge of statistics as it applies to verification/ validation testing and process control, and previous use of statistical analysis software, such as Minitab.</li> <li>A work style of hands-on involvement with all phases of projects.</li> <li>Excellent documentation skills, attention to detail and accuracy.</li> <li>Team player, flexible multitask, good written/oral communicator.</li> <li>Must be organized and able to coordinate activities with internal departments and outside vendors.</li> <li>Experience in supplier audit and ASQ certification is a plus.</li> </ul>