Quality Engineer
BHI Energy
Reno, NV
Job description
Position Summary
The Quality Engineer, ensures the quality system requirements are effectively maintained in accordance with 21 CFR 820, ISO 13485, ISO 14971 and international regulations as applicable.*Perform receiving inspection activities for material conformance, product inspection, and review of lot history records.
*Check daily shipments for compliance to sales order and verification of lot information.
*Evaluate, document and control nonconforming material as required.
*Coordinate supplier corrective action activities and address supplier quality issues.
*Perform substantive review of engineering changes to evaluate risk, safety, and compliance with Quality System requirements and applicable regulatory requirements.
*Perform document control activities including establishing and maintaining the controlled document files and document log and processing document change orders.