Medical Device Supplier Quality Engineer — CAPA & Improvement Lead

Shifamed; Los Gatos (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

Supira Medical, a clinical-stage Shifamed Portfolio Company, is seeking a Supplier Quality Engineer to ensure supplier and component quality for a high-flow pVAD. This is a three-month contract with full-time hours (40 hours per week).

You will collaborate with suppliers and cross-functional teams to drive quality improvements and change controls. The role requires a Bachelor’s in engineering and 5+ years in supplier or product quality within medical devices.

Qualifications

• Bachelor’s degree in engineering and 5+ years in related field.
• Experience with FDA QMSR, ISO 13485/9001, ISO 14971.

Responsibilities

• Collaborate with suppliers, contract manufacturers, and partners to ensure robust materials, components, and processes.
• Lead supplier qualification, audits, requalification, and supplier quality agreements.
• Own and drive supplier quality projects, initiatives, and continuous improvement efforts.
• Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.
• Monitor supplier performance metrics, identify risks, and drive improvement actions.
• Manage supplier corrective action processes (SCARs), including tracking and effectiveness.
• Support and/or lead supplier-related CAPAs and NCRs.

Skills

Communication skills

Root cause analysis

Collaboration

Education

Bachelor's in engineering

Tools

SCAR tracking

CAPA management

Job description

Supira Medical, a clinical-stage Shifamed Portfolio Company, is seeking a Supplier Quality Engineer to ensure supplier and component quality for a high-flow pVAD. This is a three-month contract with full-time hours (40 hours per week).

You will collaborate with suppliers and cross-functional teams to drive quality improvements and change controls. The role requires a Bachelor’s in engineering and 5+ years in supplier or product quality within medical devices.