Quality Engineer, Complaints
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, CA.
The Quality Engineer – Complaints, position will be based in San Clemente, CA and will act as the liaison between customer service, medical safety and manufacturing, R&D, and other pertinent departments in the process of screening, tracking investigating and reporting customer complaints.
· Process and analyze product complaints according to Policies and Standard Operating Procedures.
· Perform and write complaints investigation report
· Ensure standard process is followed and data is consistent
· Support internal and external audits and inspections
· Review and analyze device history records for product associated with complaints in an effort to determine whether anything that occurred in the manufacturing process may have caused or contributed to the customer complaint.
· Interface with Customer Service, Engineering, and Medical Safety departments to ensure complaints are opened and processed in a timely manner
· Ensure complaint records, Regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), global regulatory standards and internal procedures.
· Run reports to track status of complaints
· Conduct root cause analysis, drive corrective and preventive actions.
· Close complaint investigation in timely manner
· This position will also perform other duties as assigned.
· At least three years related experience in quality assurance in a regulated environment; experience in medical device industry a plus.
· Knowledge of medical device manufacturing preferred.
· Excellent documentation skills, attention to detail and accuracy
· Team player, flexible multitask, good written/oral communicator
· Must be organized and able to coordinate activities with internal departments and outside vendors.
· Ability to problem solve
· Proficient computer application skills i.e. Excel, knowledge of ISO 13485, FDA GMPs.
· Bachelor’s degree
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.