Senior QC Technician - Medical Devices (Onsite)

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

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