Sr. Supplier Quality Engineer II

Scorpion Therapeutics; Aliso Viejo (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Glaukos seeks a Supplier Quality Engineer II to support supplier quality for medical devices and pharmaceuticals. You will manage supplier qualification, onboarding, risk assessments, and record-keeping.

On-site in Aliso Viejo, CA with periodic travel for audits, investigations and corrective actions; collaborate cross-functionally to ensure compliant supplier changes and maintain FDA/QSR and GMP standards.

Qualifications

• Bachelor's degree in Engineering, Science, Quality or related field.
• 2+ years in Supplier Quality or manufacturing quality in a regulated environment.
• Experience with supplier qualification, audits, and CAPA.
• Knowledge of FDA QSR, GMP, ISO 13485; root cause analysis.
• Strong communication, organizational, and multitasking skills.

Responsibilities

• manage supplier qualification, onboarding, risk assessments, and record-keeping;
• monitor supplier performance, initiate and track SCARs, investigations, root cause analysis, and corrective actions;
• support supplier audits and assessments, document findings, and coordinate follow-up;
• collaborate internally and externally to resolve quality issues and implement compliant supplier changes;
• travel periodically for audits and reviews.

Skills

Supplier Quality

CAPA

Audits

Root Cause

FDA QSR

GMP

ISO 13485

Communication

Organization

Multitasking

Education

Bachelor's in Engineering, Science, Quality, or related

Job description

Role

Supplier Quality Engineer II supporting supplier quality for medical devices and pharmaceuticals at Glaukos.

Responsibilities

• manage supplier qualification, onboarding, risk assessments, and record-keeping;
• monitor supplier performance, initiate and track SCARs, investigations, root cause analysis, and corrective actions;
• support supplier audits and assessments, document findings, and coordinate follow-up;
• collaborate internally and externally to resolve quality issues and implement compliant supplier changes;
• travel periodically for audits and reviews.

Requirements

• Bachelor's in Engineering, Science, Quality, or related;
• 2+ years in Supplier Quality, Quality Engineering, or manufacturing quality in a regulated environment;
• experience with supplier qualification, audits, and CAPA;
• knowledge of FDA QSR, GMP, ISO 13485, and root cause analysis;
• strong communication, organizational, and multitasking skills.

HighValue

medical device/pharma manufacturing, supplier qualification & audits, GMP, ISO 13485, CAPA, regulated environment.

WorkSetup

on-site Aliso Viejo, CA; periodic travel.