Sr. Quality Engineer
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Senior Quality Engineer will support the development and manufacturing of Class III medical devices. This individual will work with Applied Research, Product Development and Manufacturing to resolve product quality issues. The Senior Quality Engineer will also support manufacturing process changes, product design improvements and the implementation of new products
Primary responsibilities include working in Quality Engineering and with other functional groups in support of implementation and scale up of new products/process development activities.
Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
Reviews process changes and resolves product quality issues.
Develop and establish effective quality control
Write, review and/or approve process and product validation protocols and reports, equipment qualifications, document change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process
Provides technical assistance/oversight in defining and conducting both internal and external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Writes, performs, and/or reviews technical documents such as Validation Protocols, Test Procedures, and Test Reports.
Provides technical support in areas including validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, testing requirements and methods, quality equipment, specifications, vendor quality, among others.
Responsible for conducting, documenting and maintaining risk analyses for all development products and complying with risk analysis, design control, and any other related procedures.
Develop and manage equipment and facility (including clean room) requirements, design, maintenance and validation programs.
Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
Performs other quality-related duties as assigned by management.
Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
Assist in complaint analysis as appropriate.
Train, coach, and guide lower level employees on routine procedures.
Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluates data and identifies trends in order to develop innovative solutions.
Performs other duties assigned as needed.
5-7 years of medical device quality engineering experience
Knowledge, Skills, and Abilities
Strong knowledge of medical device manufacturing
Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques)
Working understanding of GMP and ISO 13845 requirements
A work style of hands-on involvement with all phases of projects
Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
Excellent documentation skills with attention to detail and accuracy
Team player, good written/oral communicator
Must be organized and able to coordinate activities with internal departments and outside vendors
Bachelor’s Degree in Engineering
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 ourprofile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
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.