Shift: G Shift 6:00pm-6:00am (Thursday, Friday, Saturday every other Wednesday)

Responsibilities:

• Perform comprehensive review of Device History Records (DHRs) to ensure completeness, accuracy, and compliance with approved procedures, Device Master Record (DMR), and regulatory requirements (e.g., FDA 21 CFR 820.184, ISO 13485).

• Verify all required manufacturing and quality records are present, including:

  • Traceability documentation (lot numbers, serial numbers, components)

  • In-process and final inspection results

  • Test results and acceptance criteria compliance

• Ensure no discrepancies, missing data, or documentation errors exist prior to product release.

• Support or execute final product release decisions based on DHR review outcomes.

• Ensure all entries within the DHR adhere to Good Documentation Practices (GDP) requirements, Legibility, accuracy, and completeness, corrections.

• Real-time documentation and traceability of actions

• Identify and escalate data integrity issues and support remediation.

• Identify documentation errors, nonconformances, or deviations during DHR review.

• Support Nonconformances (NCs), deviation documentation.

• Ensure discrepancies are fully investigated, documented, and approved prior to DHR closure.

• Verify that corrective actions are implemented and properly documented within the record.

• Verify full end-to-end traceability of materials and components like matching quantities and correct association to work orders and finished goods.

• Perform reconciliation activities to ensure that all components are accounted for and documented accurately.

• Ensure DHRs are inspection-ready at all times for internal audits, FDA inspections, and customer audits.

• Support audit activities by retrieving and explaining DHR documentation

• Maintain compliance with internal quality systems and external regulatory standards.

• Cross-functional Collaboration with Manufacturing, Quality Engineering and Document Control.

• Provide feedback on documentation errors and trends to drive continuous improvement.

• Support training efforts to improve documentation accuracy and compliance.

• Track and report DHR review metrics such as Right-first-time, Common documentation errors and review turnaround time.

• Identify recurring issues and support process improvements to enhance efficiency and compliance.

• Utilize electronic Quality Management Systems (eQMS) and/or ERP systems to: Review, approve DHRs, and ensure version control of documents.

• Maintain proper documentation filing and archival practices per retention requirements.

• Provide real-time support to manufacturing to prevent documentation errors before they occur.

• Ensure proper use of forms and adherence to approved procedures on the production floor.