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Quality Assurance Engineer- Job id 4038

Bothell, WA

Company Description

Nextgen Technologies Inc

Job Description

Basic requirements 
[1] Bachelor's or Master's Degree in Mechanical Engineering [preferred] or Electrical Engineering. 
[2] 3-5 years experience in a product development environment, preferably with a quality focus. 
[3] Experienced in statistical analysis of test results [preferably using Minitab]. 
[4] Experienced in writing test reports documenting results of verification tests. 

Nice to haves 
[1] Knowledge of 21 CFR part 820 and FDA requirements for Medical devices [Class I minimum]. 
[2] Experienced in application of Quality Assurance methods and tools. 

Key Areas of Responsibility 
[1] Support of Quality Project Leader in generation of test plan in support of project milestones. 
[2] Coordinate execution of verification tests of prototypes and of final product. 
[3] Statistical analysis of results of verification tests and comparison to acceptance criteria. 
[4] Documentation of results of verification tests in test reports. 
[5] Support of technical team in analyis of root cause when results do not meet acceptance criteria. 
[6] Communicate status of verification activities in support of milestone consolidation.

Qualifications

Basic requirements 
[1] Bachelor's or Master's Degree in Mechanical Engineering [preferred] or Electrical Engineering. 
[2] 3-5 years experience in a product development environment, preferably with a quality focus. 
[3] Experienced in statistical analysis of test results [preferably using Minitab]. 
[4] Experienced in writing test reports documenting results of verification tests. 

Nice to haves 
[1] Knowledge of 21 CFR part 820 and FDA requirements for Medical devices [Class I minimum]. 
[2] Experienced in application of Quality Assurance methods and tools. 

Key Areas of Responsibility 
[1] Support of Quality Project Leader in generation of test plan in support of project milestones. 
[2] Coordinate execution of verification tests of prototypes and of final product. 
[3] Statistical analysis of results of verification tests and comparison to acceptance criteria. 
[4] Documentation of results of verification tests in test reports. 
[5] Support of technical team in analyis of root cause when results do not meet acceptance criteria. 
[6] Communicate status of verification activities in support of milestone consolidation.

Additional Information

In person Interview.