Glaukos is Growing! Looking for an Experienced Principal Quality Engineer – Medical Device
The Principal Quality Engineer, Medical Device Design Assurance position will be based in Aliso Viejo, CA and will directly support the development of innovative ocular medical devices.
This position will provide quality engineering support in design, development and commercialization of medical device and combination products.
What will you do?
Provide quality engineering support in design, development and commercialization of medical device and combination products.
Responsible for management of quality aspects of design controls and ensuring that there is clear traceability from design planning to commercialization.
Ensure robust final product testing is designed, developed, and implemented.
Review design history technical files for conformance to applicable requirements and regulatory standards. Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc.
Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
Implement and support product reliability assessments.
Facilitate the application of design controls in product development and sustaining changes
Manage design control and master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, Test method validation.
Review new or modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues.
Post Market Surveillance & Risk Management
Manage risk management process and post market feedback review and updates.
Continuously improve the risk management process.
Perform or support audits (internal, external, and by regulatory agencies) and risk-based supplier assessments.
Provide product understanding and support during audits.
Other Duties as Assigned
Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.
Bachelor’s Degree in Engineering, Science or related field.
12+ years of work experience in a production or engineering environment and 8+ years as an engineering technician work.
5+ years of medical device experience required, 10+ years preferred.
3+ years of leadership required, 5+ years preferred.
Knowledge, Skills, and Abilities
Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements.
Strong knowledge of medical device manufacturing.
Knowledge in sterilization and laboratory testing.
ASQ certifications preferred. CQA, CBA, CQE
Excellent documentation skills, 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.
Founded in 1998, Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases.
Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is located in Aliso Viejo, California, and we have additional locations in the United States, Canada, United Kingdom, Germany, Japan, Australia and Brazil.