Facility design and controls including environmental monitoring-new facility design
Process validation strategy and implementation
Ensure that quality systems are robust and compliant, providing solutions to operational or quality issues
Technology Subject Matter Expert:
Facilitate manufacturing and quality improvements projects.
Assess and improve quality system processes through data monitoring and trend analysis.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving technical issues.
Develop and improve quality business processes
Computerized systems validation
Implement change control processes
Risk management activities
Lead Investigations and CAPAs
Senior Level: 8+ years direct industry experience
Must have excellent documentation skills
Attention to detail and accuracy
Team player, good written/oral communicator
Able to thrive in a small, entrepreneurial environment
Must be organize and able to coordinate activities with internal departments and outside vendors
Bachelor’s degree, in a science or engineering field. Advanced degrees or qualifications in Quality Assurance desired.
About Glaukos Corporation
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.