Sr. Quality Engineer II / Sr. Quality Specialist II
Glaukos Corporation · San Clemente, CA · 1 mo ago
Quality AssuranceFull-time
Join a team that’s redefining the future of ophthalmic treatment. We’re seeking a senior quality professional to support the manufacturing and continuous improvement of our innovative combination products (pharmaceutical and medical device).
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 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, ensuring that Quality System records are completed in accordance with guidelines and in a timely manner.
Requirements
- 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.
About the role
This is 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, this role is for you.