Supplier Quality Engineer II

Glaukos Corporation; San Clemente (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Glaukos Corporation in Aliso Viejo, CA is seeking a Supplier Quality Engineer II to drive supplier quality for medical devices and pharmaceutical products. The role collaborates with Quality, R&D, Manufacturing, Regulatory Affairs, and suppliers to ensure materials and services meet regulatory standards and company quality expectations.

You will support qualification, audits, corrective actions, and supplier performance, travel to supplier sites, and help maintain compliant supplier changes.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related technical discipline.
• 2+ years of experience in Supplier Quality or a related quality role in a regulated environment.
• Experience with supplier qualification, supplier audits, supplier performance monitoring, or corrective action activities.
• Knowledge of FDA QSR, GMP, ISO 13485, CAPA, nonconformance management, and root cause analysis.
• Strong communication and cross-functional collaboration.
• 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.

Skills

Communication

Organization

Attention to detail

Multi-priority management

Education

Bachelor's degree in Engineering/Science/Quality or related technical discipline

Tools

eQMS

ERP systems

Microsoft 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.