Senior Supplier Quality Engineer - Medical Devices & Audits

Cordis, LLC; Irvine (CA); On-site; USD 112,000 - 165,000; Full time

Job summary

Cordis, LLC, in partnership with Selution, seeks a Principal Supplier Quality Engineer to ensure supplier quality across drug-device products. You will qualify new suppliers, assess components, manage performance, and drive corrective actions to meet regulatory requirements.

Collaborate with R&D and operations, lead supplier audits, and mentor teams while traveling up to 20%. The role requires a Lead Auditor certification and extensive experience in ISO 13485, FDA QSR, and EU MDR.

Qualifications

• Bachelor’s degree in engineering, quality, or related field.
• Minimum 8 years in supplier quality engineering or related role.
• Strong knowledge of supplier qualification, validation, and QMS.
• Experience conducting supplier audits and SCAR processes.
• Regulatory knowledge: ISO 13485, FDA QMSR, EU MDR.
• Willing to travel up to 20% for audits.
• Lead Auditor certification required.

Responsibilities

• Lead supplier qualification processes.
• Perform supplier assessments, audits, and reviews.
• Qualify components to specs and performance criteria.
• Manage supplier performance, non-conformances, and CAPAs.
• Plan and execute supplier audits per standards.

Skills

Supplier qualification

Audits

SCAR processing

Regulatory compliance

Travel up to 20%

Education

Bachelor’s degree in engineering or quality

Master’s degree preferred

Lead Auditor certification

Tools

Lead Auditor certification

Job description

Cordis, LLC, in partnership with Selution, seeks a Principal Supplier Quality Engineer to ensure supplier quality across drug-device products. You will qualify new suppliers, assess components, manage performance, and drive corrective actions to meet regulatory requirements.

Collaborate with R&D and operations, lead supplier audits, and mentor teams while traveling up to 20%. The role requires a Lead Auditor certification and extensive experience in ISO 13485, FDA QSR, and EU MDR.