Senior Quality Assurance Engineer

3 weeks ago


Littleton, United States Katalyst Healthcares and Life Sciences Full time

Job Summary:

Katalyst Healthcares and Life Sciences is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Evaluate requirements for quality and completeness to ensure they meet user needs
  • Develop test methods to evaluate X-ray image quality and consistency
  • Reduce test burden through automation of existing and new testing
  • Test advanced image reconstruction and processing algorithms
  • Design custom test phantoms and fixtures with internal and external teams
  • Ensure compliance with standards and regulations, including ISO and FDA QSR
  • Participate in product development phases, including requirements, design, usability, risk assessment, and defects
  • Provide technical leadership and mentoring to test engineers
  • Identify and catalog software defects in assigned functional areas
  • Assist in triage, investigation, and resolution of software defects related to X-ray image quality
  • Plan and execute test process improvements to enhance Test Engineering team performance
  • Generate test plans and protocols based on product requirements and project needs
  • Document and report test results
  • Effectively communicate and present findings, problems, and solutions within the team
  • Maintain excellent working relationships with team members and stakeholders
  • Perform duties in compliance with the Quality System and environmental, health, and safety regulations

Requirements:

  • Solid understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971, 62304, and 13485, and EU MDR


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