Sr Supplier Quality Engineer, Selution

Cordis; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Join a leading medical equipment manufacturer as a Senior Supplier Quality Engineer. Drive supplier compliance, ensure quality standards, and collaborate across teams to support new product introductions. This role offers a chance to impact lives through innovative cardiovascular solutions.

Qualifications

• 5–8 years of experience in supplier quality, manufacturing, or auditing roles.
• Skilled in SCAR, CAPA, FMEA, and audit processes.

Responsibilities

• Lead qualification of new suppliers and components.
• Plan, conduct, and report supplier audits.
• Manage and monitor supplier KPIs including quality and delivery.

Skills

Communication

Quality Assurance

Supplier Management

Education

Bachelor’s degree in Engineering

Tools

ISO 13485

ISO 9001

FDA requirements

Job description

Join to apply for the Sr Supplier Quality Engineer, Selution role at Cordis

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients, Cordis is leading the way in delivering transformative medical solutions.

At Cordis, we’re teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative, and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

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

• Bachelor’s degree in Engineering, Quality, or a related field.
• 5–8 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%).

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Medical Equipment Manufacturing