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.