Quality Assurance Technician II (Fixed-Term)

Summary of Duties

The Quality Assurance Technician/Intern is a lower-level supporting role responsible for assisting Post Market Surveillance and Recall/Field Action personnel with quality system documentation, product tracking, inspection support, data entry, record maintenance, and administrative execution of quality and recall-related activities within a regulated medical device environment.

This position is a fixed-term opportunity currently expected to run through March 2027.

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.

Required Skills and Competencies

• Strong attention to detail and ability to follow written procedures accurately.
• Good written and verbal communication skills.
• Ability to organize records, manage trackers, and maintain accurate documentation.
• Basic problem-solving skills and ability to identify missing, inconsistent, or incomplete information.
• Ability to work independently on routine assignments and escalate issues appropriately.
• Ability to support multiple priorities in a regulated, deadline-driven environment.