Sr. Quality Engineer II bei Glaukos Corporation
Glaukos Corporation · San Clemente, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in San Clemente
Sr. Quality Engineer II – Medical Devices (Ophthalmology)
Join a team that’s redefining the future of ophthalmic treatment. We’re seeking a Sr. Quality Engineer II to support the manufacturing and continuous improvement of our innovative medical devices. In this role, you’ll ensure flawless product transfers into production, lead risk management initiatives, and champion quality across operations, development, and compliance.
What You’ll Do:
- Drive quality on the manufacturing floor – from nonconformance investigations to process optimization.
- Lead risk management activities and maintain compliance with ISO 14971.
- Ensure sterility assurance with gamma sterilization oversight, dose audits, and environmental monitoring.
- Support product validation (IQ/OQ/PQ), CAPAs, and quality system improvements.
- Collaborate with R&D, Operations, Clinical, and Regulatory teams to bring new products to market and elevate existing ones.
- Act as a quality leader, guiding audits and embedding a culture of compliance and excellence.
What You Bring:
- 8+ years of relevant experience (5+ years in medical devices required; 10+ preferred).
- Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
- Background in sterilization methods (gamma preferred) and lab testing.
- Bachelor’s degree in Engineering, Science, or related field.
- ASQ certifications (CQE, CQA, CBA) a plus.
- Detail-oriented, highly organized, and a natural collaborator.
Why Join Us?
This is more than a job – it’s a chance to shape life-changing devices that help people see the world more clearly. If you thrive on solving complex quality challenges, influencing cross-functional teams, and raising the bar in medical device manufacturing, we want to meet you.
Company
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
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 in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
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.
