ESSENTIAL FUNCTIONS PERFORMED
• Maintain accurate and complete quality records in accordance with approved procedures and document control requirements.
• Assist with data entry, filing, indexing, and organization of quality system records.
• Support review of records for completeness, accuracy, legibility, and traceability.
• Assist with maintaining controlled forms, logs, trackers, and department databases.
• Ensure documentation is maintained in an inspection-ready state.
• Support Recall Coordinators with administrative execution of product recalls, corrections, removals, advisory notices, and field actions.
• Assist with customer response tracking, effectiveness check documentation, and follow-up logs.
• Compile and organize recall correspondence, return documentation, certificates of destruction, and related objective evidence.
• Maintain recall trackers and escalate overdue or incomplete responses to the assigned Recall Coordinator.
• Support reconciliation of affected product, returned product, destroyed product, and customer acknowledgments.
Inspection, Product Evaluation, and Sample Handling
• Perform or assist with visual inspections, returned product checks, sample labeling, and basic product documentation under supervision.
• Document inspection observations clearly and accurately using approved forms and procedures.
• Support containment, segregation, and tracking of returned or nonconforming product as directed.
• Assist with maintaining chain of custody, traceability, and storage of product samples or returned devices.
• Enter and verify information in quality databases, spreadsheets, eQMS platforms, or other tracking systems.