EDHR Reviewer - Quality (Molding)

EDHR Reviewer (Molding)

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 process 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.

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

Pay Range (Applicable to Illinois)$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 click.appcast.io 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).