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Principal Software Quality Engineer (Medical Device) (Bellevue)
Principal Software Quality Engineer (Medical Device) (Bellevue)Staftonic LLC • Bellevue, WA, US
Principal Software Quality Engineer (Medical Device) (Bellevue)

Principal Software Quality Engineer (Medical Device) (Bellevue)

Staftonic LLC • Bellevue, WA, US
1 day ago
Job type
  • Part-time
Job description

Principal Software Quality Engineer (Medical Device)

Bellevue, Washington

Long Term Project

Key Responsibilities :

  • Oversee design control, risk management, verification, and validation for software and hardware.
  • Ensure compliance with FDA 21 CFR 820, ISO 13485 / 14971, IEC 60601, 62304, and 62366.
  • Manage risk files (RMF, FMEA) and design documentation.
  • Perform software quality reviews, including code, security, and BOM oversight.
  • Support CAPA, process improvements, and quality system updates.

Qualifications :

  • 8+ years in medical device quality engineering.
  • Experience in both embedded and non-embedded software.
  • Proficient with statistical tools (e.g., Minitab).
  • B.S. / M.S. in Engineering or related field.
  • ASQ CQE or Six Sigma certification preferred.
  • Bonus : AI, cloud, or SaMD experience.
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    Principal Quality Engineer • Bellevue, WA, US

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