EDHR Reviewer - Quality (Molding)

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Job Summary

General Purpose

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

Job Title – EDHR Reviewer (Molding)

Location – Buffalo Grove, IL

Work Hours – 0800a-0430pm M-F

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

• 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

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.

AW20

What you'll receive for the great work you provide:

• 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

Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.

Job Posting Start Date 08-17-2026 Job Posting End Date 08-24-2026

The base pay range for this position is provided below. The final base rate offered will be determined using job-related, non-discriminatory criteria, including but not limited to experience, qualifications, geographic location, education, external market data, and internal equity.

$21.61 USD - $29.18 USD Hourly

Job Category

Quality

Is Sponsorship Available?

No

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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email View email address on us.fitly.work and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).