Senior SQE - Lead Global Supplier Quality & Compliance

Cordis, LLC; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Cordis, LLC in Irvine, CA seeks a Senior Supplier Quality Engineer to drive supplier quality, qualification, audits and CAPA within a medical device environment. You will partner with R&D, Operations and Regulatory to ensure ISO 13485 and FDA compliance, monitor supplier performance, investigate non-conformances, and lead SCAR closures with travel up to 20%.

This senior role requires 5+ years in supplier quality or auditing and a engineering/quality degree.

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 across cross-functional teams and external suppliers.
• Willing to travel as needed (up to 20%).

Responsibilities

• Lead qualification of new suppliers and components.
• Plan, conduct, and report supplier audits (on-site and remote).
• Manage and monitor supplier KPIs including quality, delivery, and responsiveness.
• Lead investigations of supplier non-conformances, root cause analysis, and corrective actions.
• Track SCARs to closure.
• Collaborate with R&D, Operations, and Regulatory teams to ensure quality during development and launch.
• Advise suppliers on regulatory changes and ensure compliance.

Skills

Supplier qualification

Audits

KPIs monitoring

SCAR management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in engineering or quality

Job description

Cordis, LLC in Irvine, CA seeks a Senior Supplier Quality Engineer to drive supplier quality, qualification, audits and CAPA within a medical device environment. You will partner with R&D, Operations and Regulatory to ensure ISO 13485 and FDA compliance, monitor supplier performance, investigate non-conformances, and lead SCAR closures with travel up to 20%.

This senior role requires 5+ years in supplier quality or auditing and a engineering/quality degree.