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  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).