Quality Control Inspector

Quality Assurance San Jose, California


Description

Responsibilities

  • Support manufacturing schedules by providing inspections of incoming materials, in-process materials and finished devices as assigned for electromechanical as well as disposable products.
  • Complete First Article Inspections including supporting documentation.
  • Identify and record any product quality problem(s).
  • Review device history records and perform product release.
  • Support inspection of engineering prototypes.
  • Initiate and/or make suggestions to improve working processes or product (i.e. quality, productivity, etc.)/
  • Set up and/or organize QC work stations and receiving quarantine area.
  • Review and audit quality records and manufacturing processes including device history records.

Education and Experience

  • High school diploma or equivalent work experience.
  • 5+ years plus experience in quality control or manufacturing environment; experience in medical device industry or comparable capital equipment industry required.

Qualifications

  • Experience in a medical device, FDA QSR regulated industry, including ISO 13485 requirements.
  • Experience inspecting disposable product, electro-mechanical assemblies, as well as printed material and labeling.
  • Be able to interpret the sampling plans.
  • Experience using optical inspection systems.
  • Ability to work independently with little supervision.
  • Demonstrated proficiency utilizing metrology/inspection tools (i.e., microscope, caliper, micrometer, digital multimeter, hi-pot tester, optical comparator).
  • Be detailed oriented.
  • Data entry experience is a plus.
  • Strong interpersonal and communication skills.
  • Strong understanding of Microsoft Office tools, eg, MS Word, Excel, Outlook.