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Sr. Quality Engineer
Sr. Quality EngineerKatalyst Healthcares and Life Sciences • Bellevue, WA, United States
Sr. Quality Engineer

Sr. Quality Engineer

Katalyst Healthcares and Life Sciences • Bellevue, WA, United States
9 hours ago
Job type
  • Full-time
Job description

Responsibilities :

  • Lead quality engineering activities for new hardware / software medical device development, including design control and risk management.
  • Develop and maintain Risk Management File (RMF), dFMEA, pFMEA, hazards analysis, and risk reports.
  • Review / approve Design History File (DHF), design inputs / outputs, verification & validation plans, test protocols, and reports.
  • Provide statistical guidance for design verification, validation, and test method validation.
  • ct as SME for software quality, including code reviews, cybersecurity, software BOM, and AI / cloud-based solutions.
  • Support design transfer, production anomalies, CAPA closure, and quality system updates based on regulations.

Requirements :

  • Strong knowledge of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366.
  • Experience in medical device hardware, software, and electromechanical systems.
  • Skilled with statistical tools (Minitab), Microsoft Office, Adobe Acrobat.
  • SQ CQE and / or Six Sigma Green / Black Belt preferred.
  • I, SaMD, AAMI TIR45, and cloud infrastructure experience a plus.
  • B.S. / M.S. in Engineering (biomedical, software, electrical, or related).
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    Sr Quality Engineer • Bellevue, WA, United States