Device History Record Review

Position Summary: 

Review device history records (DHR) for good manufacturing and documentation practices, accuracy and completeness. Close orders in computer, scan and file documents for retrieval. Scan certification paperwork.  

Essential Duties and 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.  

Knowledge, Skills
& Competencies:  

• Strong computer skills with experience in a Windows operating
   environment. 
• Proficiency in Microsoft Excel.  
• Experience is ISO/FDA environment preferred. 
• Knowledge of raw materials, production processes, and quality
   control.  
• Knowledge of documentation systems, and archiving and control
   techniques preferred.  
• 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.   

Work Environment: 

· The noise level in the work environment is
usually moderate. 

· Includes exposure to sounds and noise levels
that can be distracting or uncomfortable. 

· Includes exposure to production and
manufacturing work areas.  

· Work environment is temperature controlled.  

The work environment
 described here is representative of that which an employee encounters while
 performing the essential functions of this job. Reasonable accommodations may be made to
 enable individuals with disabilities to perform the essential functions.  

Physical
Requirements:  

• While performing the duties of this job the employee is
   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.  

The physical demands described here are representative of
those that must be met by an employee to successfully perform the essential
functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform
these essential functions.  

Education,
Certifications, and/or Licenses Requirements:   

• High school diploma or equivalent