Senior Supplier Quality Engineer

Cordis, LLC; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Cordis, LLC in Irvine, CA seeks a Senior Supplier Quality Engineer to drive supplier quality, qualification, audits and CAPA within a medical device environment. You will partner with R&D, Operations and Regulatory to ensure ISO 13485 and FDA compliance, monitor supplier performance, investigate non-conformances, and lead SCAR closures with travel up to 20%.

This senior role requires 5+ years in supplier quality or auditing and a engineering/quality degree.

Qualifications

• Bachelor’s degree in engineering, quality, or a related field.
• 5+ years of experience in supplier quality, manufacturing, or auditing roles.
• Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
• Skilled in SCAR, CAPA, FMEA, and audit processes.
• Effective communicator across cross-functional teams and external suppliers.
• Willing to travel as needed (up to 20%).

Responsibilities

• Lead qualification of new suppliers and components.
• Plan, conduct, and report supplier audits (on-site and remote).
• Manage and monitor supplier KPIs including quality, delivery, and responsiveness.
• Lead investigations of supplier non-conformances, root cause analysis, and corrective actions.
• Track SCARs to closure.
• Collaborate with R&D, Operations, and Regulatory teams to ensure quality during development and launch.
• Advise suppliers on regulatory changes and ensure compliance.

Skills

Supplier qualification

Audits

KPIs monitoring

SCAR management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in engineering or quality

Job description

Overview

Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Senior Supplier Quality Engineer (Senior SQE) is responsible for driving supplier compliance and continuous improvement. This role ensures suppliers meet the company’s quality standards and regulatory requirements through effective qualification, auditing, performance monitoring, and corrective action processes. The Senior SQE plays a key part in risk mitigation and supports new product introductions, collaborating closely with R&D, operations, and regulatory teams.

Key Responsibilities:

• Supplier Qualification & Approvals: Lead qualification of new suppliers and new components. Review supplier technical capabilities and quality systems to ensure alignment with company requirements.
• Audits & Assessments: Plan, conduct, and report supplier audits (on-site and remote). Follow up on audit findings and verify implementation of corrective actions.
• Supplier Performance Monitoring: Manage and monitor supplier KPIs including quality, delivery, and responsiveness. Identify trends and lead continuous improvement plans.
• Issue Resolution & SCAR Management: Lead investigations of supplier non-conformances, working with suppliers to complete root cause analysis and implementing corrective actions. Track SCARs to closure.
• Cross-Functional Collaboration: Partner with R&D, Operations, and Regulatory teams to ensure quality during product development and launch. Provide technical support and quality input for supplier-related matters.
• Regulatory Compliance: Ensure supplier processes comply with ISO 13485, FDA, and other applicable standards. Stay up to date with regulatory changes and advise suppliers as needed.

Qualifications

Required Qualifications:

• Bachelor’s degree in engineering, quality, or a related field.
• 5+ years of experience in supplier quality, manufacturing, or auditing roles.
• Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
• Skilled in SCAR, CAPA, FMEA, and audit processes.
• Effective communicator, able to work with cross-functional teams and external suppliers.
• Willing to travel as needed (up to 20%).