Document Control Coordinator
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
The Document Control Coordinator, based in San Clemente, California, will be 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.
• Administering the CATSWeb Document Control database.
• Provide support to all personnel for document control
• Creating reports in the CATSWeb system for Management Review, Trending requests, etc.
• Maintaining the document control and training modules within the CATSWeb system
• Addressing quality system gaps within the document control system stemming from audits.
• Administering the CATSWeb Training database.
• Provide support to all personnel for training
• Monitor the status of the training process
• Provide reports on the status of training
• Coordinate group training when needed
Design History Files:
• Working with project managers on compiling and maintaining the DHFs.
• Other duties as assigned
• 8+ years industry experience in a leadership role
Knowledge, Skills, and Abilities:
• Must have excellent documentation skills
• Attention to detail and accuracy a must
• Medical device experience and working knowledge of QSR
• Medical device complaint experience preferred
• Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
• Team player, good written/oral communicator
• Able to thrive in a small, entrepreneurial environment
• Must be organized and able to coordinate activities with internal departments and outside vendors
Bachelor's degree, preferably in a science
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our 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 is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.