Job DescriptionSupplier Quality Engineer II (Aliso Viejo, CA)
Glaukos is seeking a Supplier Quality Engineer II to support supplier quality activities for medical device and pharmaceutical products. This role partners cross-functionally with Quality, R&D Engineering, Manufacturing, Supply Chain, Product Development, Regulatory Affairs, third-party logistics partners, and suppliers to help ensure purchased materials, components, and services meet regulatory requirements and company quality standards.
What You'll Do
- Support supplier qualification, onboarding, risk assessments, and supplier record maintenance.
- Monitor supplier performance, identify quality trends, and assist with scorecards and improvement initiatives.
- Initiate and track Supplier Corrective Action Requests (SCARs), investigations, root cause analysis, and corrective actions.
- Support supplier audits and assessments, including documentation of findings and follow-up actions.
- Collaborate with internal teams and suppliers to resolve quality concerns and support compliant supplier changes.
- Travel periodically to supplier locations for audits, assessments, and business reviews.
What We're Looking For
- Bachelor's degree in Engineering, Science, Quality, or a related technical discipline.
- 2+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related quality discipline in a regulated environment.
- Experience supporting supplier qualification, supplier audits, supplier performance monitoring, or corrective action activities.
- Working knowledge of FDA Quality System Regulations, GMP, ISO 13485, CAPA, nonconformance management, and root cause analysis.
- Strong communication, organization, attention to detail, and ability to manage multiple priorities in a cross-functional environment.
- Proficiency with quality systems, eQMS, ERP systems, and Microsoft Office applications.
At Glaukos, team members contribute to meaningful work that supports innovation in ophthalmology and helps improve the lives of patients. We are committed to building an inclusive workplace where people with diverse backgrounds, experiences, and perspectives can thrive.
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