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Katalyst HealthCares & Life Sciences
Quality EngineerKatalyst HealthCares & Life Sciences • Salt Lake, UT
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Quality Engineer

Quality Engineer

Katalyst HealthCares & Life Sciences • Salt Lake, UT
30+ days ago
Job type
  • Full-time
Job description

Roles & Responsibilities:
  • Lead and support design verification and validation activities, including test method development and execution.
  • Perform sample size selection and statistical data analysis to support design decisions and risk assessments.
  • Conduct process capability studies and support design transfer to manufacturing.
  • Ensure compliance with FDA, ISO , and other relevant regulatory standards.
  • Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing.
  • Review and approve design documentation including Design History Files (DHF),risk management files and test protocols.
  • Provide technical guidance and mentorship to junior QEs offshore.
  • Support CAPA investigations related to design issues and contribute to continuous improvement initiatives.
  • Certified Quality Engineer (CQE) or equivalent certification.
  • Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms.
  • Familiarity with risk management standards (ISO ) and usability engineering (IEC ).
  • Good Knowledge of Medical Devices & QMS (ISO , CFR Part ).

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Quality Engineer • Salt Lake, UT

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