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Quality Engineer II

Job in Memphis, Shelby County, Tennessee, 38118, USA
Listing for: Artech
Full Time position
Listed on 2026-06-27
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below

Quality Engineer II

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

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

Root Cause Analysis / Investigations

  • Failure analysis
  • Corrective and Preventive Actions (CAPA)
  • Data-driven problem solving

Process & Equipment Validation

  • Process validation / equipment validation
  • Software or spreadsheet validation
  • Validation documentation and execution
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