EDHR Reviewer - Quality (Molding)

Principal Accountabilities

• Responsible for review and quality release of Electronic Device History Record (DHR) documents and forms
• Provides guidance and assistance to support teams in development of Electronic Device History Record processes and forms
• Acts as a Subject Matter Expert for Electronic Device History Record (DHR) processes
• Supports active resolution for production issues as it relates to EDHR Completion (i.e. nonconformances and CAPAs)
• Reports EDHR status to Quality, Operations, and Order Management teams
• Interacts with customers to complete EDHR reviews as needed
• Supports the activities to review batch records, compile the EDHR and approval of in-process product and finished goods
• Supports final product release for medical device product
• Prepares graphs or charts of data or enters data into computer for analysis
• Downloads quality information from quality system to be used for EDHRs
• Supports EDHR Reviewer for Molding

Required Experience

• High School Diploma or equivalent, technical training, or equivalent experience
• Typically requires a minimum of 4 years of related experience
• Demonstrates advanced technical skills
• Demonstrates detailed functional knowledge and may lead process
• Has awareness of new technologies/ techniques
• Requires the ability to utilize charts, tables, and specifications, and operate a variety of measuring instruments
• Basic understanding of typical quality tools, such as 8d, statistical process control, FMEA, and control plans
• ISO/FDA Auditing experience a plus
• Use of the following tools may be required: Office Skills: telephones, data entry, office software to include word processing, spreadsheet, and presentation package