Sr. Quality Engineer II
2 days ago
Sr. Quality Engineer II / Sr. Quality Specialist II
Join a team that's redefining the future of ophthalmic treatment. We're seeking a Sr. Quality Engineer II or Sr. Quality Specialist II to support the manufacturing and continuous improvement of our innovative combination products (pharmaceutical and medical device). 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:
- Work with the Manufacturing and QC Analytical Departments as Quality Assurance (QA) representative providing QA oversight and support to ensure compliance to GMP.
- Drive quality on the manufacturing floor - from nonconformance investigations to process optimization.
- Identify compliance risks and to ensure quality and regulatory compliance with 21 CFR Parts 210/211, 820, ISO 13485, USP and ICH guidelines.
- 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.
- Author and perform quality review of deviations, out of specification result investigations, non-conformances, and CAPA, as needed ensuring that Quality System records are completed in accordance with guidelines and performed in a timely manner.
- Bachelor's degree in Engineering, Science, or related field.
- 8+ years of relevant experience (5+ years in pharmaceutical required; 10+ preferred).
- Experience with QC analytical method validation, raw material and final product testing, and stability programs in a regulated environment.
- Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, 21 CFR Parts 210/211, USP and ICH guidelines.
- 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 pharmaceutical and medical device manufacturing, we want to meet you.
#GKOSUS
About Us
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.
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