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Quality Technician

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Location
MN
Job Type
Direct Hire
Date
Nov 07, 2018
Job ID
2638596
Our very early stage medical device start-up client is adding a Quality Technician to their team! Since they are a small company they are looking for a self-motivated person that likes wearing lots of hats and is willing to help with any task needed.

Your role with the company: 
  • Oversee cleanroom activities
  • Document Control activities
    • Establish and maintain Device History Records
    • Generate and process documentation through the Change Order System
  • Test method development
    • Work with Engineering to establish new test methods to verify product design and function
  • Handles Calibration Management; including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required
  • Perform incoming receiving inspections
    • Record inspection findings on inspection record forms, lab notebooks, and other appropriate mediums
  • Responsible for assigned aspects of the Quality Assurance department operations to assure compliance with the Quality System Regulations (QSR), ISO and MDD requirements
  • Oversees Quality System procedures and compliance with their requirements
  • Carries out responsibilities as outlined for product quality, safety, health and environmental policies
 Desired Profile:
  • High school degree or equivalent; 4 year college degree preferred
      Must Have:
  • Five years minimum medical device industry experience.
  • Three years-minimum direct quality assurance experience with a successful track record.
        Key Skills:
  • Lab equipment skills: calipers, micrometer, vision system, tensile tester
  • Excellent interpersonal, organization, computer and project management skills.
  • Excellent oral and writing skills to communicate technical information.
  • Demonstrated sound judgment in reviewing technical data, protocols, and applying quality principles
  • Ability to handle and be trusted with confidential and/or sensitive information.
  • Ability to work in a fast-paced, constantly changing environment.
  • Ability to be flexible and to handle multiple projects in an organized, timely manner