EDHR Reviewer - Quality (Molding)

Flex•Buffalo Grove, IL

3d•$22 - $29•Onsite

About The Position

Supports Electronic Device History Record (DHR) Reviewer in preparing and reviewing the Electronics Device History Records. This role is responsible for the review and quality release of Electronic Device History Record (DHR) documents and forms, providing guidance and assistance to support teams in the development of Electronic Device History Record processes and forms, and acting as a Subject Matter Expert for Electronic Device History Record (DHR) processes. The position also 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, and interacts with customers to complete EDHR reviews as needed. Additionally, it supports activities to review batch records, compile the EDHR and approval of in-process product and finished goods, and supports final product release for medical device product. The role provides immediate quality support to the manufacturing line to document and address concerns, prepares graphs or charts of data or enters data into computer for analysis, and downloads quality information from the quality system to be used for EDHRs. Supports EDHR Reviewer for Molding.

Requirements

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.
Office Skills: telephones, data entry, office software to include word processing, spreadsheet, and presentation package.

Nice To Haves

ISO/FDA Auditing experience a plus.

Responsibilities

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
Support 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.
Interact with customers to complete EDHR reviews as needed.
Support the activities to review batch records, compile the EDHR and approval of in-process product and finished goods.
Support final product release for medical device product
Provides immediate quality support to the manufacturing line to document and address concerns
Prepares graphs or charts of data or enters data into computer for analysis.
Download quality information from quality system to be used for EDHRs.
Supports EDHR Reviewer for Molding