Medical Device NPD Quality Engineer

Miami, FL

Job ID: 132595 Industry: Medical Device

 

Medical Device NPD Quality Engineer

Environment:

Our client is a large medical device manufacturer that develops a number of Class II & III medical devices. They are currently in need of a New Product Development Quality Engineer to support day-to-day NPD activities from a Quality Engineering standpoint.

Responsibilities:

The NPD Quality Engineer will  be responsible for writing NPD Quality documentation related to Design Controls, Design Verification & Validation, Process Validation, Risk Management (DFMEA). This individual will actively participate in New Product Development teams and Design Change activities, writing and executing protocols, data analysis, and report generation. Maintains Process & Product Risk Analysis to ISO 14971 requirements.

Required:
  • Medical Device (Class II & III)
  • NPD Quality Engineering
  • Design Controls
  • Design & Process V&V
  • Risk Management (DFMEA & PFMEA)
  • MiniTab  Experience
  • Knowledge of Audit Process
  • FDA Quality System Regulations & ISO Standards
  • Engineering Degree

Plus:
  • Supplier Quality Engineering

Job Type: Contract  

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