Perform receiving, in-process, and/or final inspections of purchased and customer-owned parts for disposable medical devices and electro-mechanical assemblies.
Perform activities related to the documentation, control, disposition, and root cause analysis of nonconforming material.
Review Device History Records and other documentation for compliance with established procedures and Good Documentation Practices.
Provide assistance, guidance, and oversight to Manufacturing during rework activities.
Accurately document inspection and testing results.
Maintain controlled document files and test records in a timely and accurate manner.
Maintain a thorough understanding of individual component specifications, blueprints, and sampling plans.
Write accurate and detailed nonconforming material reports.
Communicate discrepancies or concerns with suppliers and initiate and follow up on Supplier Corrective Action Preventive Action (SCAPA) requests.
Conduct and document roving process, equipment setup, and system audits using written procedures as audit standards.
Monitor critical equipment and instrumentation to ensure proper operation and calibration.
Provide support to Quality Engineers with testing and data collection during validation activities.
Provide support to the QA Supervisor in maintaining the calibration program and collecting bioburden samples and data.
Numbers & Facts
Location
Youngsville, NC
Skills
Blueprintsunmatched
Calibrationunmatched
Corrective Actionunmatched
Data Collectionunmatched
Document Managementunmatched
Documentationunmatched
Electromechanical Assemblyunmatched
File Maintenanceunmatched
Information Technology/Systems Auditunmatched
Instrumentationunmatched
Manufacturingunmatched
Materials Analysisunmatched
Medical Disposablesunmatched
Medical Equipmentunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Root Cause Analysisunmatched
Specimen Collectionunmatched
Systems Administration/Managementunmatched
Test Dataunmatched
Testingunmatched
Time Managementunmatched
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