Job Summary

Quality Engineer - Complaint Investigations

  • Location:
    Bloomington, Indiana
  • Job reference:
  • Category:
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A Quality Engineer - Complaint Investigations job near Bloomington, IN is available via Modis Engineering. This Quality Engineer - Complaint Investigations job will be involved in managing customer complaints. Ability to work within a team environment and help guide other engineers through the various quality processes.

Quality Engineer - Complaint Investigations job responsibilities include:
* Interface with appropriate internal/external groups to gather necessary information to conduct timely complaint investigations.
* Execute risk assessment as needed during the course of the complaint investigation.
* Possess and utilize knowledge of formal problem solving tools and appropriate application of those tools.
* Perform root cause analysis as necessary.
* Independently conduct complaint investigations following Cook’s relevant Quality System Procedures.
* Remediate complaint files as necessary.
* Possess and utilize excellent technical writing skills.
* Possess and utilize extensive working knowledge of risk management per ISO 13485, and 21 CFR 820.198 and 820.200.

• BS Engineering or Technical Degree.
• 7 years or more of FDA regulated experience.
• Previous experience with determining gaps and providing the needed solutions for compliance.

If you are interested in this Quality Engineer - Complaint Investigations job near Bloomington, IN please click APPLY NOW. For other opportunities available at Modis Engineering go to If you have questions about the position please contact Jim Cullen at 317-842-2870 or

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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.

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