Supplier Quality Engineer (SQE) / Incoming Quality Engineer (AR)

POSITION OBJECTIVE

Ensure that materials, components, and services provided by suppliers meet all technical, quality, and regulatory requirements, safeguarding product conformity, traceability, and compliance with applicable standards (ISO 13485, FDA 21 CFR 820, IPC).

· Ensure incoming inspections are performed according to sampling plans, engineering specifications, and internal procedures.

· Supervise and develop Incoming Inspection personnel.

· Verify inspection records are complete, accurate, and fully traceable.

· Review Certificates of Conformance (CoC), Certificates of Analysis, and supporting technical documentation.

· Ensure proper identification, segregation, and control of nonconforming material.

· Lead Supplier Corrective Action Requests (SCAR).

· Drive root cause analysis activities with suppliers (8D, 5 Why, Fishbone).

· Monitor supplier performance metrics (PPM, OTD, RMA trends, recurring defects).

· Participate in supplier audits when required.

· Perform risk assessments for critical suppliers and key components.

· Support supplier qualification and onboarding processes.

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· Ensure compliance with ISO 13485 and FDA 21 CFR 820 requirements.

· Maintain full lot and component traceability.

· Support internal, customer, and regulatory audits.

· Ensure proper control and retention of quality records.

· Propose and implement improvements to the incoming inspection process.

· Optimize sampling plans based on supplier performance data.

· Drive defect prevention initiatives to reduce 100% inspection when appropriate.

· Collaborate with Engineering and Supply Chain in new supplier approvals.

· Supplier PPM

· SCAR closure cycle time

· Incoming inspection adherence to sampling plans