Lexingtonmedical

Senior Quality Control Technician

Bedford, MA. Posted 23 days ago

The role

You will inspect and disposition surgical stapler components using GD&T and vision systems. You will perform incoming, in-process, and final inspections while reviewing lots on hold and documenting nonconforming material.

What you will do

  • Perform incoming, in-process, and final inspection of AEON™ stapler components and finished devices.
  • Interpret GD&T callouts and choose measurement methods.
  • Run inspections on OGP and Keyence vision systems.
  • Perform dimensional and visual inspections with calipers, micrometers, and optical comparators.
  • Review lots on hold and questionable inspection results.
  • Identify, segregate, and document nonconforming material.
  • Write clear, complete NCRs.
  • Review inspection documentation to release accepted material.
  • Maintain lot and component traceability to Good Documentation Practices.
  • Recommend improvements to inspection methods, work instructions, and fixtures.

Required qualifications

  • 4+ years of quality inspection experience in medical device, aerospace, or other precision manufacturing.
  • Strong working knowledge of GD&T.
  • Ability to read complex, custom-designed engineering drawings.
  • Hands-on experience using vision measurement systems such as OGP SmartScope or Keyence.
  • Proficiency with precision measurement tools including calipers, micrometers, and optical comparators.
  • Proficiency with Microsoft Excel for recording and summarizing inspection data.
  • Experience writing and documenting nonconformance reports (NCRs).
  • Experience working in a cleanroom or controlled manufacturing environment.
  • Experience following Good Documentation Practices.
  • Experience working with engineers on drawing reviews.
  • Technical certificate, associate degree, or equivalent hands-on experience in quality, metrology, or manufacturing technology.

Nice to have

  • vision system programming
  • CMM experience
  • ASQ CQI or CQT certification
  • experience under ISO 13485 and FDA quality system requirements

About the company

Lexington Medical designs and manufactures AEON™ surgical stapling technology at its headquarters in Bedford, Massachusetts. Engineering, manufacturing, and quality work together under one roof.

Senior Quality Control Technician at Lexingtonmedical | JobZoey