Quality Engineer II, Design
- San Clemente, CA
The Quality Engineer II, Design, based in San Clemente, CA directly supports the full product lifecycle of innovative ocular medical device development; responsibilities include the execution of design control deliverables, risk management activities, Design History File compliance and leading assessment/implementation of design changes to already approved medical devices. This role will support the development of new product designs as well as the maintenance and enhancements of existing products.
Responsibilities & Work Experience:
Working with development teams to assure:
• Clear and concise user requirements, product specifications, plans, verification and validation studies, risk management strategies and other relevant design control deliverables,
• Test protocols that include qualified and repeatable test methods, appropriate risk-based sample sizes and clear test instructions that produce meaningful data,
• Robust reports which include appropriately analyzed test data to support regulatory submissions and product launches,
• Transfer plans that include complete DMR documents, quality control plans, training plans, approved suppliers and process validations,
• Complete and accurate design history files.
• Maintain the risk management plans for all product lines ensuring compliance with ISO 14971.
• Leads Risk Management activities for effective product development and operational activities.
• Ensure feedback loops are implemented and effective.
• Integrate risk management throughout the quality management system.
• Provide risk analysis leadership for all departments.
• Ensure all design control and risk management documents are maintained and meet regulatory requirements.
• Participate in and lead investigations for CAPA, manufacturing or quality system projects.
• Assess and improve quality system processes through data monitoring and trend analysis.
• May participate in internal and supplier audits, conducting audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Mentor for technical guidance for identifying and resolving quality issues.
Other Duties as Assigned:
• Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.
• 4 to 7 years work experience in a production or engineering environment and 3+ years as an engineering technician work.
• 3+ years of medical device experience required.
• Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements
• Excellent documentation skills with attention to detail and accuracy
• Must be self-motivated, goal-driven and results-oriented team player
• Must be organized and able to coordinate activities with internal departments
Bachelor's Degree in Science or Engineering
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.
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.
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