Senior Supplier Quality Engineer

Cordis; Irvine (CA); On-site; USD 98,000 - 131,000; Full time

Job summary

Cordis, based in Irvine, is seeking a Senior Supplier Quality Engineer to drive supplier qualification, audits, and performance monitoring, ensuring suppliers meet ISO 13485, ISO 9001, and FDA requirements and supporting new product introductions.

You will collaborate with R&D, Operations, and Regulatory teams to provide quality input, lead SCAR and CAPA investigations, track corrective actions, and sustain regulatory compliance while traveling up to 20% as needed.

Qualifications

• Bachelor’s degree in engineering, quality, or a related field.
• 5+ years of supplier quality, manufacturing, or auditing experience.
• Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
• Experience with SCAR, CAPA, FMEA and audit processes.
• Excellent cross-functional collaboration and communication.
• Willingness to travel up to 20%.

Responsibilities

• Lead supplier qualification and approvals.
• Plan, conduct, and report supplier audits (on-site and remote).
• Monitor supplier KPIs and drive continuous improvement.
• Lead investigations of supplier non-conformances and manage SCARs.
• Collaborate with R&D, Operations, and Regulatory teams to ensure quality during product development and launch.
• Ensure supplier processes comply with ISO 13485, FDA, and other standards.

Skills

Quality systems knowledge

Cross-functional collaboration

Audit & root cause analysis

Communication

Travel up to 20%

Education

Bachelor’s degree in engineering, quality, or related field

Job description

Las Visión de Conjunto

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.

Responsabilidades

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.

Calificaciones

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%).

Preferred Qualifications

Preferred Qualifications:

• Experience in medical device or high-tech manufacturing.
• Six Sigma, ASQ CSQP, or Lead Auditor certification.
• Familiarity with risk management tools and supplier performance platforms.

Pay / CompensationThe expected pre-tax pay rate for this position is $97,900 - $130,900 per yearActual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, and they share a passion for improving people's lives. Diversity not only includes race and gender identity but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming.