Medical Device Quality Engineer

Boston, MA

Job ID: 130934 Industry: Med
 
 

Medical Device 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  Quality Engineer to come in and help with a technology transfer. This role is very much a hands on execution position.

This person will representing new product development in support of the  technology transfer.

Responsibilities:

The Quality Engineer will  be responsible for dealing with Design Controls, Design Verification & Validation,  Risk Management (DFMEA), and documentation approval. This individual will actively participate in New Product Development teams and Design Change activities, writing and executing protocols, data analysis, and report generation. This role is focused around Medical Device design initiatives, so experience in those areas are important to have experience in. Other responsibilities will include but are not limited to;

  • Proficiency in Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control

  • Conducts, and supports the development of test methods, process validation / verification, and product validation / verification.

  • Support supply chain issue resolution / product investigations

Required:
  • Medical Device (Class II & III)
  • Design Controls
  • IQ OQ PQ
  • Design & Process V&V
  • Risk Management (DFMEA)
  • Technology Transfer Experience

Job Type: Contract 

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