Senior Quality Control Technician New

Lexington Medical, Inc.; Bedford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Lexington Medical, Inc. designs and manufactures AEON™ surgical stapling technology from our Bedford, MA headquarters.

The Senior Quality Control Technician will inspect incoming components, read complex GD&T callouts, and determine measurement methods using OGP and Keyence systems along with calipers, micrometers, and optical comparators. You’ll review inspection documentation, write NCRs, and help refine the QC process while ensuring material release with full lot traceability in a cleanroom

Qualifications

• 4+ years of quality inspection experience in medical device, aerospace, or other precision manufacturing.
• Strong working knowledge of GD&T, with ability to read complex, custom‑designed engineering drawings and explain measurement approach.
• Hands‑on experience using vision measurement systems such as OGP SmartScope or Keyence.
• Proficiency with precision measurement tools including calipers, micrometers, and optical comparators, and with Excel for recording inspection data.
• Experience writing and documenting nonconformance reports (NCRs).
• Experience working in a cleanroom or controlled manufacturing environment and following Good Documentation Practices.
• Experience working with engineers on drawing reviews, including giving feedback that led to drawing updates.
• Technical certificate, associate degree, or equivalent hands‑on experience in quality, metrology, or manufacturing technology.
• A plus: vision system programming, CMM experience, ASQ CQI or CQT certification, or experience under ISO 13485 and FDA quality system requirements.

Responsibilities

• Perform incoming, in-process, and final inspection of AEON™ stapler components and finished devices per documented procedures and engineering drawings.
• Interpret GD&T callouts such as position, profile, flatness, and runout, including datum structures, and choose the right measurement method for each feature.
• Run inspections on OGP and Keyence vision systems, and recognize when a result is driven by fixturing or measurement setup rather than the part itself.
• Perform dimensional and visual inspections with calipers, micrometers, and optical comparators.
• Review lots on hold and questionable inspection results, confirm whether parts truly fail, and determine disposition so only genuine issues go to engineering.
• Identify, segregate, and document nonconforming material, and write clear, complete NCRs that follow established engineering disposition plans.
• Review inspection documentation to release accepted material, and maintain full lot and component traceability to Good Documentation Practices in a regulated medical device cleanroom environment.
• Recommend improvements to inspection methods, work instructions, and fixtures based on what you see at the bench.

Skills

GD&T

Reading drawings

Vision measurement systems

Calipers

Micrometers

Optical comparators

Excel

Education

Technical certificate

Associate degree

Tools

OGP SmartScope

Keyence

CMM

Job description

As a Senior Quality Control Technician at Lexington Medical, you will inspect and disposition surgical stapler components using GD&T and OGP and Keyence vision systems. Engineering, manufacturing, and quality share one building in Bedford, so when a part looks out of spec, you are the one who confirms whether it truly fails or was fixtured or measured incorrectly, before it ever reaches engineering.

About Lexington Medical

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our headquarters in Bedford, Massachusetts, just outside Boston. Our products are used in minimally invasive surgery, where precision, reliability, and quality matter every time. Because engineering, manufacturing, and quality work together under one roof, the people building and supporting our products are close to both the process and the decisions behind it.

About the Role

As a Senior Quality Control Technician at Lexington Medical, you will be the experienced inspector behind the incoming components and assemblies that go into our AEON™ Endostapler. Your time will be split roughly evenly between hands‑on inspection and reviewing lots on hold: reading engineering drawings with complex GD&T callouts, deciding how each feature should be measured, and using OGP and Keyence vision inspection systems alongside calipers, micrometers, and optical comparators.

When a part looks out of spec, you will check the drawing, the fixturing, and the measurement before making the call, so engineering only sees true failures. You will review inspection documentation to release accepted material, write clear NCRs that follow the dispositions engineering has already defined, and help refine the inspection process from inside QC.

Responsibilities

• Perform incoming, in-process, and final inspection of AEON™ stapler components and finished devices per documented procedures and engineering drawings.
• Interpret GD&T callouts such as position, profile, flatness, and runout, including datum structures, and choose the right measurement method for each feature.
• Run inspections on OGP and Keyence vision systems, and recognize when a result is driven by fixturing or measurement setup rather than the part itself.
• Perform dimensional and visual inspections with calipers, micrometers, and optical comparators.
• Review lots on hold and questionable inspection results, confirm whether parts truly fail, and determine disposition so only genuine issues go to engineering.
• Identify, segregate, and document nonconforming material, and write clear, complete NCRs that follow established engineering disposition plans.
• Review inspection documentation to release accepted material, and maintain full lot and component traceability to Good Documentation Practices in a regulated medical device cleanroom environment.
• Recommend improvements to inspection methods, work instructions, and fixtures based on what you see at the bench.

Qualifications

• 4+ years of quality inspection experience in medical device, aerospace, or other precision manufacturing.
• Strong working knowledge of GD&T, with the ability to read complex, custom‑designed engineering drawings (not only off‑the‑shelf components) and explain how you would measure a given callout.
• Hands‑on experience using vision measurement systems such as OGP SmartScope or Keyence.
• Proficiency with precision measurement tools including calipers, micrometers, and optical comparators, and 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 and following Good Documentation Practices.
• Experience working with engineers on drawing reviews, including giving feedback that led to drawing updates.
• Technical certificate, associate degree, or equivalent hands‑on experience in quality, metrology, or manufacturing technology.
• A plus: vision system programming, CMM experience, ASQ CQI or CQT certification, or experience under ISO 13485 and FDA quality system requirements.

What Success Looks Like

• By 3 months, you are inspecting independently across our incoming component families on the OGP and Keyence systems, and catching fixturing or measurement errors before they turn into engineering reviews.
• By 1 year, you are confidently dispositioning lots on hold, far fewer parts go to engineering for review, and you have improved at least one inspection method, fixture, or work instruction.
• What makes someone excellent here: you catch problems before they reach the line, and you can explain the reasoning behind every measurement to a technician or an engineer.

Location & Work Arrangement

This position is based at our headquarters in Bedford, Massachusetts, in the Greater Boston area, and is an on‑site role. This is a full‑time, day‑shift position, Monday through Friday, 9:00 am to 5:00 pm.