Quality Engineer

1 month ago

Louisville, United States Wicked Technologies Full time

We are seeking a skilled and detail-oriented Quality Engineer with experience in medical device product development and manufacturing.to join our team. As a Quality Engineer, you will be responsible for ensuring the quality and reliability of our products through rigorous testing, analysis and documentation.


You will work closely with our development and manufacturing teams to identify and resolve any issues and at times with our suppliers


Responsibilities:

  • Lead risk management process with product development team.
  • Develop and execute V&V plans and test cases to thoroughly test electro-mechanical and software applications.
  • Perform functional, regression, and performance testing to identify any defects or issues.
  • Defining and approving processes: Creating documentation, developing quality tests, defining criteria for test results, and ensuring the proper use of tools, materials, and procedures.
  • Monitoring and testing: Specifying how to Inspect raw materials, components, mechanical systems, or final products, and reporting any issues.
  • Collaborate with the development team to understand requirements and provide feedback on design and functionality.
  • Preventing and fixing issues: Playing a key role in preventing issues or fixing them if they arise for new products and products in production.
  • Conduct root cause analysis on defects to determine the underlying cause and recommend appropriate solutions.
  • NC and CAPA coordinator.


Skills:

  • Strong knowledge of quality assurance methodologies, tools, and processes.
  • Familiarity with software development lifecycle (SDLC) methodologies.
  • Understanding of FDA regulations for medical devices.
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Business analysis skills to understand requirements and translate them into effective test cases.


Apply now to join our dynamic team

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