Strategic Supplier Quality Engineer - Medical Devices

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

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.