Sr. Quality Engineer II / Sr. Quality Specialist II
Ensures flawless manufacturing and compliance of ophthalmic combination products by leading quality initiatives, risk management, and regulatory adherence in a GMP-regulated environment.
- Compensation
- Not disclosed
- Location
- San Clemente, CA, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 5+ years
- Category
- Industrial engineering
- Posted
Skills
Full description
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.
What You Bring:
- 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.
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