Device History Record Review

Exalta Group•Village of Somers, WI

6d•Onsite

About The Position

This position involves reviewing device history records (DHR) to ensure adherence to good manufacturing and documentation practices, accuracy, and completeness. The role includes closing orders in the computer system, scanning and filing documents for retrieval, and scanning certification paperwork.

Requirements

Strong computer skills with experience in a Windows operating environment.
Proficiency in Microsoft Excel.
Knowledge of raw materials, production processes, and quality control.
Ability to be highly accurate with a high attention to detail, proven organization and coordination skills.
Basic knowledge and understanding of blueprints.
Ability to read and comprehend work instructions.
Ability to repeat the same mental activities over and over.
Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work.
Ability to work in a team environment as well as autonomously.
Ability to communicate and interact effectively, professionally and constructively.
Regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
Ability to lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Ability to sit for up to 12 hours per day.
Ability to view computer monitor for extended periods of time throughout the work day.

Nice To Haves

Experience is ISO/FDA environment preferred.
Knowledge of documentation systems, and archiving and control techniques preferred.

Responsibilities

Review device history records to ensure accuracy and completeness.
Review device history records to ensure compliance with GMPs, SOPs and GDPs.
Oversee the review of completed production related documents to ensure GDP compliance, and assist operators in correcting errors.
Close shop orders in computer system and scan DHRs to electronic file for retrieval.
Create certification packages for customers according to their documentation requirements.
Scan certification paperwork to file electronically for retrieval.
Review work orders prior to shipping product.
Track various metrics – number of orders reviewed, number of GMP/GDP errors, etc.
Assists quality technicians by locating, pulling and copying product/component certifications to send with product shipment to customers.
Review contract review forms to determine documentation and label requirements for each shipment.
Review customer specs and update customer requirement spreadsheet as needed for customer required documentation.
Create and print customer required labels for shipments using Zebra software/printer and customer website.
Respond to customer documentation requests.
Coordinate with BMI’s offsite file storage facility for pick up as needed and ensure compliance of the facility to governing standards.
Order supplies as needed for offsite file storage.
Support complaint investigations by compiling production manufacturing documents.
Interact with other departments to coordinate DHR requirements.
Work with vendors regarding GDPs.
Meet and maintain established efficiency and effectiveness standards for the DHR process.
Ensure proper and complete documentation off all data in ERP system and required paperwork.
Complete all documentation per ISO 13485 and FDA requirements.
All other duties as assigned.