Medical Device NPD Quality Engineer

San Jose, CA

Job ID: 127588 Industry: Med

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.

Responsibilities:

The NPD Quality Engineer will  be responsible for writing NPD Quality documentation related to Design Controls, Design Verification & Validation, Process Validation, and Risk Management (DFMEA). This individual will actively participate with the New Product Development  team and Design Change activities, writing and executing protocols, data analysis, and report generation. Maintains Process & Product Risk Analysis to ISO 14971 requirements. It would also be a huge plus if this individual has Supplier Quality experience such as setting up  Supplier Quality Agreements,  New Supplier selection, working with Contract Manufacturers, etc.

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

Plus:
  • Supplier Quality

Job Type: Contract

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