Supplier Quality Engineer

Glaukos Corporation; San Clemente, Northern (CA, KY); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Glaukos Corporation is seeking a Supplier Quality Engineer II to support supplier quality activities for medical device and pharmaceutical products, based on-site at our Aliso Viejo, CA office. You will partner with Quality, R&D Engineering, Manufacturing, Supply Chain, and Regulatory Affairs to ensure purchased materials meet regulatory and company quality standards.

Responsibilities include supplier qualification, onboarding, risk assessment, monitoring supplier performance, SCARs, root-cause

Qualifications

• 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.

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.

Skills

Supplier Quality

Quality Engineering

Regulated Environment

CAPA

Root Cause Analysis

Cross-functional Collaboration

Documentation

Microsoft Office

Communication

Organizational Skills

Attention to Detail

Multitasking

Education

Bachelor’s degree in Engineering/Science/Quality

Tools

eQMS

ERP Systems

Quality Systems

MS Office

Job description

Supplier Quality Engineer II (Aliso Viejo, CA)*

*This is an ON-SITE position based out of corporate HQ office

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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