Quality Engineer Lead

Seattle, WA

Job ID: 128234 Industry: Med

Quality Engineer Lead

Environment:
Our client is a leading provider of class III devices. Our client is working on a new product introduction and they are  seeking an experienced quality engineering consultant to be their quality lead, with primary responsibility to ensure that they are adhering to their quality system.  They are currently in the planning and requirements generation phase, and would expect this person to be heavily involved in helping with customer requirements, system requirements, and project sub-plans.  This is for a class III PMA medical device

Principle Duties and Responsibilities:
Our client is looking for a Quality Engineer Lead to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. They will be participating in the change management process to assure the products or services continue to meet customer requirements. They will establish the principles of product and service quality evaluation and control for the system. They will provide independent oversight and review of the project deliverables throughout the product lifecycle. Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. The ideal candidate can lead quality related problem solving and root cause analysis during design and manufacturing. This person assigned to project team will be responsible to ensure that hardware design meets quality and compliance standards for every milestone.

Required:

Medical Device

Electromechanical devices or class III products

Quality System

Design Quality

Desired:

Defibrillators

 

Job Type: Contract

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