Quality Operations Technician
Position Summary
The Quality Operations Technician is responsible for the cleaning, inspection, functional testing, and quality verification of returned surgical trays and spinal instrumentation. This role ensures all instruments meet established quality standards, regulatory requirements, and company specifications prior to reprocessing or redeployment. The technician plays a critical role in maintaining product safety, functionality, and compliance within a regulated medical device environment.
![]()
Key Responsibilities
Clean, wash, and decontaminate returned surgical trays and spinal instrumentation according to approved work instructions and quality procedures
Perform system-specific functional testing on spinal instrumentation to verify proper operation and performance
Inspect instruments for wear, damage, corrosion, or defects that could result in non-conformance
Verify that cannulas are clear, lumens are unobstructed, and moving components function as intended
Ensure all components are present, correctly assembled, and compliant with device specifications
Identify, document, and escalate non-conforming products in accordance with Quality System procedures
Accurately record inspection results, functional test outcomes, and processing activities in the applicable system (ERP, QMS, or tracking logs)
Maintain a clean, organized, and compliant work area in accordance with safety and quality requirements
Support audits, inspections, and continuous improvement initiatives as needed
Collaborate with Quality, Operations, and Engineering teams to resolve quality-related issues
![]()
Required Qualifications
High school diploma or equivalent required
Experience in a medical device, healthcare, sterile processing, or regulated manufacturing environment preferred
Strong attention to detail and ability to identify subtle defects or functional issues
Ability to follow detailed written procedures and work instructions
Basic computer skills and experience with electronic documentation systems
Ability to stand for extended periods and perform repetitive tasks
Manual dexterity and ability to handle delicate surgical instruments
![]()
Preferred Qualifications
Experience with spinal instrumentation or surgical trays
Knowledge of GMP, FDA regulations, ISO 13485, or quality systems
Familiarity with inspection tools and functional testing methods
Prior experience with ERP or quality tracking systems
![]()
Physical & Work Environment Requirements
Ability to lift up to 25–40 lbs as required
Work performed in a controlled environment with exposure to cleaning agents and processing equipment
Use of personal protective equipment (PPE) as required
![]()
Key Competencies
Attention to detail
Quality-focused mindset
Compliance and documentation accuracy
Team collaboration
Time management and organization