Quality Engineer

Eliassen GroupSan Diego, CA, US

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Quality Engineer

Our client, an industry leader in medical device manufacturing, has an excellent opportunity for a Quality Engineer to work on a 6+month contract opportunity. Work will be on-site in San Diego, CA. The Quality Engineer will lead Test Method Validation (TMV) activities including protocol development, execution, and reporting.

Rate : $50 - $55 / hr. w2

Responsibilities :

Develop and validate test methods to ensure compliance with internal and external standards.
Conduct Measurement System Analysis (MSA) including Gage Repeatability and Reproducibility (GR&R) studies to assess and improve measurement reliability.
Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements.
Analyze data using statistical tools to evaluate method performance and identify areas for improvement.
Author and maintain validation documentation including protocols, reports, and risk assessments.
Flexibility to work off shifts and overtime based on equipment availability.

Experience Requirements :

Proficiency in statistical analysis software (e.g. JMP, Minitab)

Experience authoring and maintaining validation documents

Statistical Analysis in MSA and Gauge R&R

Experience with project management tools such as JIRA, Confluence, Smartsheet

Strong problem solving skills when validating both destructive and non-destructive test methods.

Highly familiar with vision-based metrology equipment

Have a preventative mindset through anticipating potential problems.

Excellent written and oral communication skills.

Flexibility to occasionally work 2nd shift based on equipment availability.

Education Requirements :

Bachelor's degree in Engineering required, with a preference for Mechanical, Chemical, or Biomedical Engineering.

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Quality Engineer • San Diego, CA, US