Supplier Quality Engineer II

Glaukos • Aliso Viejo, CA

8d • $73,600 - $92,000 • Onsite

About The Position

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.

Requirements

• 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.

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level