EDHR Reviewer - Quality; Molding

Job Summary

Supports the Electronic Device History Record (DHR) Reviewer in preparing and reviewing the Electronics Device History Records.

EDHR Reviewer (Molding)

Buffalo Grove, IL

0800a-0430pm M-F

• 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 products
• 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
• Downloads quality information from the quality system to be used for EDHRs
• Supports EDHR Review for Molding

• 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

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

$21.61 USD - $29.18 USD hourly

No

Quality

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law.

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