Job Summary

Quality Engineer Product Non-Conformance

  • Location:
    Bloomington, Indiana
  • Job reference:
    US_EN_3_105992_327435
  • Category:
    Quality
  • Contract Type:
    Direct Hire

A Quality Engineer - Product Non-Conformance Direct Hire job in Southern Indiana is available through Modis. Our client, who is one of the best-known and most respected names in the medical devices and supplies industry, is seeking an experienced Quality Engineer - Product Non-Conformance who will be responsible for remediating deficiencies in organization’s Quality System. Review and documentation of: historical non-conformance (NC) data, assessment of current quality controls, NC severity and status of distributed product, determination of escalation to CAPA system

Quality Engineer - Product Non-Conformance job responsibilities include:

Review and documentation of: historical non-conformance (NC) data, assessment of current quality controls, NC severity and status of distributed product, determination of escalation to CAPA system, needed corrections and disposition of nonconforming material.
This work will require interaction with Production Engineering, Quality Engineering, CAPA Engineering, Production and Quality Control personnel and management, Operations Management


REQUIRED QUALIFICATIONS & EXPERIENCE:

Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
Minimum 4+ years in Quality Assurance to support development or manufacturing activities in medical device (including experience with 21CFR820 QSRs for Medical Devices)
Proficient with Minitab
Demonstrated experience in the timely, thorough, and accurate review of Product Non-conformances with the output of a Product Nonconformance Report where in there is clear documentation of the NC investigation
Ability to work collaboratively with Engineering Department, Quality Engineering and other functional groups, as needed
Multitasking to maintain progress of multiple NC investigations concurrently

If you are interested in this Quality Engineer - Product Non-Conformance then please click APPLY NOW. For other opportunities available at Modis go to www.modis.com. If you have questions about the position or would like more information, please contact Megha Kumar by email at megha.kumar@modis.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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