Senior Supplier Quality Engineer – Medical Devices Compliance

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

Job summary

Cordis, in partnership with Selution, seeks a Principal Supplier Quality Engineer to ensure supplier and component quality for drug-device products. You will lead supplier qualification, audits, non-conformances, corrective actions, and risk mitigation while collaborating with R&D and commercial teams to support development and commercialization.

Based in Irvine, CA, travel up to 20% is required. A Master’s degree and Lead Auditor certification are preferred, with 8+ years in supplier quality

Qualifications

• Bachelor’s degree in engineering, quality, or a related field; Master’s degree preferred.
• Minimum of 8 years of experience in supplier quality engineering or related roles.
• Strong knowledge of supplier qualification, component validation, and quality systems.
• Experience conducting supplier audits and SCAR processes.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 (QMSR), ISO 14971, EU MDR, and MDSAP.
• Lead Auditor certification required.
• Able to travel up to 20% for supplier audits.

Responsibilities

• Lead supplier qualification for new suppliers and ensure regulatory compliance.
• Perform supplier assessments, audits, and technical reviews.
• Qualify components and ensure adherence to product specifications.
• Conduct supplier performance reviews with KPIs.
• Drive corrective and preventive actions and supplier audits.
• Provide guidance on quality expectations and compliance improvements.
• Collaborate with R&D, Operations, and Commercial teams.
• Act as liaison between suppliers and internal teams.

Skills

Problem-solving

Analytical

Negotiation

Education

Bachelor’s degree in engineering

Master’s degree preferred

Job description

Cordis, in partnership with Selution, seeks a Principal Supplier Quality Engineer to ensure supplier and component quality for drug-device products. You will lead supplier qualification, audits, non-conformances, corrective actions, and risk mitigation while collaborating with R&D and commercial teams to support development and commercialization.

Based in Irvine, CA, travel up to 20% is required. A Master’s degree and Lead Auditor certification are preferred, with 8+ years in supplier quality