Senior Supplier Quality Engineer

Cordis • Irvine, KY

1d • $97,900 - $130,900

About The Position

Selution, in partnership with Cordis, develops and commercializes drug-device combination products for coronary and peripheral artery disease. The Senior Supplier Quality Engineer drives supplier compliance and continuous improvement, ensuring suppliers meet company quality standards and regulatory requirements through qualification, auditing, performance monitoring, and corrective action processes. The role supports risk mitigation and new product introductions in collaboration with R&D, operations, and regulatory teams.

The position includes leading qualification of suppliers and components; planning and conducting remote and on-site audits; monitoring supplier quality, delivery, and responsiveness; resolving supplier non-conformances and managing SCARs; and providing quality input throughout product development and launch. The Senior SQE also ensures supplier processes comply with ISO 13485, FDA, and other applicable requirements and advises suppliers on regulatory changes. Travel may be required up to 20%.

Requirements

• Bachelor’s degree in engineering, quality, or a related field.
• At least 5 years of experience in supplier quality, manufacturing, or auditing roles.
• Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
• Skills in SCAR, CAPA, FMEA, and audit processes.
• Effective communication skills and ability to work with cross-functional teams and external suppliers.
• Willingness to travel as needed, up to 20%.
• US work authorization; candidates requiring sponsorship for a work-authorized visa will not be considered.

Nice To Haves

• 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.

Responsibilities

• Lead qualification of new suppliers and components, reviewing technical capabilities and quality systems for alignment with company requirements.
• Plan, conduct, and report supplier audits, both on-site and remote; follow up on findings and verify corrective actions.
• Manage supplier performance indicators for quality, delivery, and responsiveness; identify trends and lead improvement plans.
• Lead investigations into supplier non-conformances, work with suppliers on root cause analysis and corrective actions, and track SCARs through closure.
• Collaborate with R&D, operations, and regulatory teams to support quality during product development and launch.
• Provide technical support and quality input on supplier-related matters.
• Ensure supplier processes comply with ISO 13485, FDA, and other applicable standards; monitor regulatory changes and advise suppliers.
• Travel as needed, up to 20%.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior