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Position Summary

  • The Engineer I, Quality Complaints will methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed.

Essential Duties & Responsibilities

  • Methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner
  • Identify critical dimensions on component drawings and submit dimensional inspection requests
  • Carry out basic standardized test methods and/or submit functional testing requests
  • Establish and maintain communication both internal and external (with the customers and regulatory personnel as needed)
  • Domestic and International Regulatory vigilance reporting is essential
  • Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
  • References existing work to complete similar projects. Improves on previous work.
  • Provides input to the product teams regarding the development of new designs, methods or processes.
  • Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
  • May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
  • Work on special projects as they arise

Knowledge & Skills

  • A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting
  • Take in and communicate information effectively
  • Communicate externally as needed, and do so in a professional manner
  • Knowledge of Microsoft Word, Excel, and Outlook
  • Has engineering foundation.
  • Expected to spend majority of time learning and best practices.
  • Has a basic understanding engineering discipline.
  • Willingness to learn/understand big picture.
  • Ability to complete projects with minimum supervision.
  • Requires the ability to provide input and recommendations that impact the completion of project goals.

Minimum Qualifications, Education & Experience

  • Must be at least 18 years of age
  • Bachelor's degree from an accredited college or university (Engineering or Technology) required.
  • 0-2 years experience
  • Prior experience in quality assurance is preferred.
  • Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

Read the full job description and apply online on the recuiter's web-site

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