Medical Device NPD Quality Engineer

Boston, MA

Job ID: 130933 Industry: Med

 

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 NPD Quality Engineer to come in and help with NPD Quality Engineering aspects of New Product Development. This role is very much a hands on execution position.

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. They will also be performing a lot of documentation approval. Maintains Process & Product Risk Analysis to ISO 14971 requirements.

Required:
  • Medical Device (Class II & III)
  • New Product Development Quality Engineering
  • Design Controls
  • IQ OQ PQ
  • Design & Process V&V
  • Risk Management (DFMEA)
  • Knowledge of Audit Process
  • FDA Quality System Regulations & ISO Standards

Job Type: Contract 

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