Quality Engineer II

Artech Information Systems LLC

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

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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Vacancy posted 2 days ago

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