Supplier Quality Engineer
Location: San Diego, CA
Name: Alere, Inc.
This role provides technical and quality support for supplier selection, qualification, and approval. There will be responsibility for ensuring that the supplier audit program is implemented in compliance with existing procedure requirements including audit schedule and execution, supplier auditor qualifications, adequacy of audit reports, and on time closure of audit non-conformances.
• Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality activities.
• Support the qualification of new suppliers/services provides according to company policy.
• Execute and support activities to ensure effective monitoring of supply chain performance including supplier corrective actions (SCAR)
• Support quality agreements with vendor.
• Manage supplier change control and work with the Operation/Quality engineering group to evaluate the change impact to product performance.
• Lead and drive proactive supplier quality tools (e.g. scorecards, supplier risk management) and participate in supplier business reviews.
• Leading and/or supporting supplier related Non-conformance and CAPA.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Understands & aware of the quality consequences which may occur from the improper performance of their specific job; awareness of device defects that may occur in their area of responsibility, including product design, V&V, manufacturing and testing activities.
Preferred educational background:
Bachelor's Degree in a biological science or engineering discipline.