Medical Device Quality Engineer (Process Validation)

Portland, OR

Job ID: 129191 Industry: Med

 

 

Medical Device QE (Process Validation)

Environment:

Our client is a large medical device manufacturer of primarily class 2 implantable devices. They are in need of a high level quality engineer to come in and support a remediation effort, specifically focused on process validation.

Scope of Work:

Our client seeks a candidate well-versed in quality engineering for medical devices. This person will have multiple process engineers reporting into them doing much of the execution portion of process validation, where as this role entails more of an oversight to process validation and providing the client with suggestions based on their experiences with other medical device companies. The consultant should be well versed in IQ OQ PQ and remediating legacy Process Validations. The client is seeking someone who can provide some leadership to the project and ensure the remediation of these validations are done adequately to FDA standards. This person will mostly be providing an assessment of what is required to properly remediate and help get the project underway.  They should be comfortable working cross functionally with all levels of the organization including mid level engineers, manufacturing, other consultants, management, etc.

Required Experience:
  • Medical Device: 5-7 plus years
  • Class 2 Implantables
  • Quality Engineering
  • Process Validation (IQ OQ PQ)
  • ISO 13485

Desired:
  • Orthopedics

Job Type: Contract

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