Glaukos Corporation · 3 months ago
Sr. Quality Engineer II / Sr. Quality Specialist II
San Clemente, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expGlaukos Corporation is redefining the future of ophthalmic treatment, and they are seeking a Sr. Quality Engineer II or Sr. Quality Specialist II to support the manufacturing and continuous improvement of their innovative combination products. The role involves ensuring compliance, driving quality initiatives, and collaborating with various teams to elevate product standards.
Health CareMedicalWellness
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Science, or related field
8+ years of relevant experience (5+ years in pharmaceutical required)
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
Detail-oriented, highly organized, and a natural collaborator
Preferred
10+ years of relevant experience
ASQ certifications (CQE, CQA, CBA)
Company
Glaukos Corporation
At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
1001-5000 employees
H1B Sponsorship
Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$121MKey Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M
Leadership Team
Alex Thurman
Senior Vice President and Chief Financial Officer
Joseph Gilliam
President & Chief Operating Officer
Recent News
2025-12-17
Orange County Business Journal
2025-11-09
Company data provided by crunchbase