L
Not Specified Permanent

New Haven, Connecticut · USA job

Quality Engineer III

LanceSoft

New Haven, Connecticut

Job description

Overview

In this contract role, you will perform quality engineering activities across product development and change initiatives. You will lead QA extended teams, ensure proper specification, inspection, and validation of components and processes. You will conduct failure analysis and risk management to prevent issues and support regulated development. You will work with cross-functional groups to implement quality tools and ensure timely project delivery. This is a hands-on role with impact on device quality and compliance in a fast-paced environment.

Responsibilities
  • Perform design verification and design for six sigma activities
  • Lead reliability engineering and component/subassembly validation
  • Evaluate subcontractors for device quality and regulatory conformance
  • Conduct failure analysis and risk management
  • Manage QA extended teams and provide leadership to QA staff
  • Track timelines and ensure proper implementation of QA tools
  • Guide divisional QA engineers and ensure consistent tool usage
  • Support other quality groups to meet project requirements
Key requirements
  • Minimum 7 years of experience in design, manufacturing, or quality engineering (medical device experience preferred)
  • Advanced degree may substitute three years of experience
  • Experience with statistical tools and methods (Minitab preferred), DOE, and software for design/development/manufacturing
  • Knowledge of statistical quality control, SPC, DOE, FMEA
  • Experience in a regulated environment
  • leadership
  • cross-functional collaboration
  • problem-solving
  • design verification
  • design for six sigma
  • reliability engineering

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