FDA Quality Engineer

FDA Quality Engineer

28 Sep 2024
Illinois, Naperville, 60563 Naperville USA

FDA Quality Engineer

Vacancy expired!




FDA Quality Engineer - 6 month expected assignment - Naperville, IL
Volt Workforce Solutions is seeking a hands-on Quality Engineer with some FDA compliance experience for their location in Naperville, IL for an estimated 6 month assignment. Extensions may be possible.
The Quality Engineer will be creating the PPAP documentation, including process flows, PFMEAs and Control Plans, working with manufacturing and process engineering. This person will also ensure all appropriate Device History Records (DHRs) and Device Master Records (DMRs) as per FDA requirements, are created and a system implemented for future programs.

What You Will Do In Your Role

  • Create Device Master Record (DMR) and Device History Record (DHR) process. Document accordingly.
  • Labeling: Work with process engineering to develop and document UDI labeling.
  • Validation: Work with process engineering to validate all equipment and processes related to FDA programs. This includes fixtures.
  • Identification: Work with maintenance to identify and log all tooling and/or fixturing for the FDA related programs.
  • Line clearance: Update the line clearance process to ensure it is in compliance with FDA requirements.
  • Calibration: Assist in determining which items do and do not require calibration and label/document accordingly.
  • Quality System: Work with all departments to ensure compliance to ISO13485 and FDA 21 CFR820 requirements. Perform internal audits as required.


The Experience You Will Bring
Requirements:
  • BS Degree in Engineering or other related field
  • At least 1 year of Quality Experience with respect to FDA 21 CFR 820 requirements
  • Experience with analysis and documentation


What Will Put You Ahead
  • 3+ years' experience in Quality Engineering in an FDA related environment
  • Working knowledge of electronic assembly, testing, molding, and stamping processes
  • Experience with Quality Systems (ISO 9001, ISO13485, and/or TS16949)

Local candidates are encouraged to apply, no relocation assistance and the role is not remote. Submit your resume today for immediate consideration! Sorry, W2 only; no third party or Corp to Corp will be considered.
If you do not meet all the qualifications for this position, be sure to visit http://jobs.volt.com to find other available positions that you may qualify for.

Volt is an Equal Opportunity Employer

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Job Details

  • ID
    JC46054010
  • State
  • City
  • Job type
    Contract
  • Salary
    $44. - $55 per hour
  • Hiring Company
    Volt Services Group
  • Date
    2022-09-23
  • Deadline
    2022-11-21
  • Category

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