Quality Technician I - 3rd shift

ComarWest Bend, WI
Onsite

About The Position

The Quality Technician I - 3rd shift will perform first piece and daily visual and dimensional analysis of finished product at required intervals as specified on the inspection plans. This role also involves performing first article inspection and evaluation, as well as floor audits of paperwork, materials, finished product, and control plans. The technician will manage non-conforming product by performing inspections, initiating containment activities, executing control procedures, and documenting results. Additionally, they will follow and communicate all plant Health, Safety, and Quality guidelines and GMP. For ISO13485, the technician will provide support and guidance to operations on the floor regarding ISO 13485 and cGMP requirements.

Requirements

  • High school or Vo-Tech graduate
  • 0-1 years’ experience in Quality Control or in a GMP Manufacturing environment
  • Proficient in understanding and learning computers and software
  • Understanding of Statistical Process Control (SPC) tools and techniques
  • Understanding of Repeatability and Reproducibility (Gauge R&R)

Nice To Haves

  • Bachelor’s degree in science, technology, engineering or significant applicable experience, training, and certifications.
  • Experience working in medical device, pharmaceutical, or food manufacturing environments.
  • Experience with visual inspection standards and processes.
  • Experience working in an ISO, cleanroom, or regulated environment.

Responsibilities

  • Perform first piece and daily visual and dimensional analysis of finished product at required intervals as specified on the inspection plans.
  • Perform first article inspection and evaluation.
  • Perform floor audits of paperwork, materials, finished product, and control plan at required intervals as specified on the inspection plans.
  • Perform inspection of non-conforming product, initiate containment activities, execute control of non-conforming product procedures and documentation of results.
  • Follow and communicate to others all plant Health, Safety and Quality guidelines and GMP.
  • Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.
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