Quality Engineer

The Quality Engineer provides support to both new product development and continuous improvement initiatives for existing product lines. This person uses statistical analysis, test method development, engineering principals, and awareness of relevant procedural and regulatory requirements to move projects and initiatives to successful completion.

Essential Job Functions:

  • Identify applicable quality standards and appropriate test methods for the assessment of product and/or process performance
  • Implement Design Control during the launch of new products and significant product design changes
  • Review designs, design changes, validation plans, and specification changes and makes recommendations relevant to compliance, risk, and performance
  • Track and review corrective and preventive actions (CAPA’s)
  • Document non-standard/nonconforming processes or product and then work with other engineers and departments to find a solution and disposition
  • Perform experiments, applying accepted design of experiment techniques
  • Author and execute test method and process validations
  • Develop sampling plans by applying attribute, variable, and sequential sampling methods
  • Analyze data by completing hypothesis testing, 2 sample t-tests, and process capability analyses
  • Prepare reports by collecting, analyzing, and summarizing data; making recommendations


  • Bachelor’s degree in engineering or other technical discipline
  • Proven record of test method development, execution of validations, and data-based decision making
  • 2-5 years of work experience in a similar role, ex. laboratory testing,documentation of test reports and test protocols, prototyping, or commercialization
  • Self-starter and comfortable being a subject matter expert within the company
  • Experience in the medical device field a plus

Other Skills/Abilities:

  • Analyzing Data/Information
  • Reporting Research Results
  • Technical Understanding
  • Quality Engineering
  • Team Leadership
  • Promoting Process Improvement
  • Developing Standards
  • Managing Processes
  • Manufacturing Methods and Procedures
  • Supports Innovation
  • Operations Research

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc