EDHR Reviewer - Quality (Molding)

Flex•Buffalo Grove, IL

5d•Onsite

About The Position

Supports Electronic Device History Record (DHR) Reviewer in preparing and reviewing the Electronics Device History Records. Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

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