Complaint Investigation Intern##Irvine##Ca

Nihon Kohden Irvine , CA 92606

Posted 2 weeks ago

Position Purpose: Complaint Handling

Process customer complaints for device reportability to FDA

  • Assess customer complaints for FDA reportability using the MDR Decision Tree

  • Create MedWatch forms for FDA submission of MDRs

  • Perform related duties as assigned.

Required Knowledge and

  • Strong communication and interpersonal skills

  • Solid analytical skills and the demonstrated ability to solve problems quickly and creatively

  • Strong organization skills and good attention to detail

  • Self-directed individual, with excellent follow through

  • Ability to work well within a team environment

  • Solid computer skills, including proficiency in MS Office suite


  • Currently enrolled as a Sophomore, Junior, or Senior in Quality Assurance/Regulatory, or related field with a 3.0/4.0 GPA or better

  • Prior related work experience preferred, but not required

Physical Requirements:

  • Sitting

  • Walking

  • Stairs

  • Direct exposure to health and safety hazards associated with production materials and equipment

  • Computer operation

Training Requirements

Training relative to Company requirements and procedures and individual job duties will be provided as outlined on the Training Requirements form. A training file containing documentation of all training received is maintained for each employee.

Job descriptions change from time to time. The Company retains the right at its sole discretion to modify, delete, or add to any of the information contained in this document.

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Complaint Investigation Intern##Irvine##Ca

Nihon Kohden