Senior Supplier Quality Engineer II - Global Med Devices

SmartRecruiters, Inc.; Aliso Viejo (CA); On-site; USD 121,000 - 148,000; Full time

Job summary

Trident Consulting is seeking a Sr. Supplier Quality Engineer II for a client in Aliso Viejo, CA. The role focuses on supplier quality oversight for medical devices/pharma products, including on-site audits and QMS compliance.

Responsibilities include managing supplier classifications, conducting audits, driving SCARs, and improving supplier performance. Requires 8+ years of experience and engineering degree; travel up to 50% for supplier visits.

Qualifications

• 8+ years of relevant working experience required.
• Strong knowledge of 21CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971 requirements. Regulatory and QA audits experience is highly desirable.
• Bachelor's Degree in Engineering required.

Responsibilities

• Review supplier requests to determine supplier risk level and qualification requirements.
• Maintain Approved Suppliers List (ASL) in Oracle and update supplier records.
• Lead supplier audits, supplier performance reviews, and corrective actions (SCARs).
• Drive continuous improvement of supplier quality management processes.
• Facilitate cross‑functional communication to ensure QA compliance and reliability.

Education

Bachelor's Degree in Engineer

Job description

Trident Consulting is seeking a Sr. Supplier Quality Engineer II for a client in Aliso Viejo, CA. The role focuses on supplier quality oversight for medical devices/pharma products, including on-site audits and QMS compliance.

Responsibilities include managing supplier classifications, conducting audits, driving SCARs, and improving supplier performance. Requires 8+ years of experience and engineering degree; travel up to 50% for supplier visits.