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IT Quality Assurance Jobs

Quality Engineer II

Artech LLC

Memphis, TN

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JOB DETAILS
SALARY
$45–$50 Per Hour
SKILLS
Code of Federal Regulations, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Equipment Validation, FDA (Food and Drug Administration), Failure Analysis, Healthcare Quality, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Manufacturing, Medical Equipment, Medical Products, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Windows Operating System, Microsoft Word, Problem Solving Skills, Process Validation, Quality Engineering, Regulations, Root Cause Analysis, Software Validation, Spreadsheets, Validation Documentation
LOCATION
Memphis, TN
POSTED
18 days ago

Job Title: Quality Engineer II
Job ID: 27026
Location: 4380 Swinnea Rd Bldg B Memphis Tennessee 38118
Duration: 12 months
Pay Rate: $45.00 - $50.00/hr on W2
 

Role Summary

Supports manufacturing quality engineering activities for new and existing medical device products. Focus on process implementation, validation, defect investigation, and compliance documentation in a regulated manufacturing environment.

Top Required Skills

  1. Medical Device Quality & Regulatory Knowledge
    • 1–3+ years experience in medical device industry
    • Familiar with FDA 21 CFR Part 820, EU MDR 2017/745
    • Knowledge of ISO 13485, ISO 14971, IEC 60601
    • Proficient in MS Office (Word, Excel, PowerPoint, Access), Windows OS
  2. Root Cause Analysis / Investigations
    • Failure analysis
    • Corrective and Preventive Actions (CAPA)
    • Data-driven problem solving
  3. Process & Equipment Validation
    • Process validation / equipment validation
    • Software or spreadsheet validation
    • Validation documentation and execution

About the Company

A

Artech LLC

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