Quality Technician

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Job Description

The Quality Technician will operate equipment and use tools to test medical devices per established processes. Assignments will include working with the Quality Manager, Production Supervisor, and Engineering to prepare and test current products being produced and performing incoming inspections on raw materials.

The Quality Technician role may also include some duties as an Assembly Technician.

Major Responsibilities
  • Follow direction of the Quality Manager, Operations Manager, or Supervisor.
  • Follow established procedures and follow Good Manufacturing Practices (GMP) requirements as appropriate.
  • Comprehend and follow test and inspection instructions, understand the acceptance criteria, interpret and document the results
  • Ensure the quality of the products manufactured by performing necessary quality checks and lot release testing. This includes collecting the required samples, testing them, documenting and reporting the results back to the production area and/or the Supervisor. It also includes checking and approving the setups of various production stations and/or equipment throughout the day.
  • Complete documentation associated with production builds and testing as required.
  • General house-keeping to ensure material trace-ability, cleanliness, and order, keeping tools, materials, and paperwork organized.
  • Quality and safety are paramount in the medical device production environment. Quality Technicians must perform with professional leadership to promote quality in all aspects of the company. This includes following all company policies and procedures as well as being a role model for others.
  • Communication is of utmost importance.
  • If quality is compromised or any unique or new quality issue is ever observed, immediately notify the Supervisor.
  • Communicate with the production lines to determine when samples need to be pulled or QC checks need to be performed.
  • Communicate with the Supervisor and Line Leads on activities and estimated times for completing them.
  • Remain visible and accessible to the production lines for effective timing of the QC activities.
  • Communicate with the Quality Manager and Supervisor to help segregate material if a non-conformance situation occurs.
  • Notify the Supervisor or Engineering if there is any issue with any inspection or production equipment.
  • Consistently communicate with the Supervisor when completed with QC activities for potential assignment in the production area for the remaining time in the shift.
  • Ability to work on feet through-out shift and lift a minimum of 30 lbs
  • Legible handwriting
  • Ability to read and understand English
  • Ability to communicate in English both verbally and written
  • Ability to perform math (addition, subtraction, multiplication, division, averages, minimums and maximums)
  • Ability to understand specifications, tolerances, and units
  • Ability to use standard measurement equipment including calipers, rulers, gauges, and microscopes
  • Familiar with QC sampling plans; ability to use a C=0 sampling plan chart
  • 6 months minimum in medical device assembly or testing
  • Experience working in a team environment

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