Sr Quality Engineer

cGxPServe

  • Bellevue, WA
  • Permanent
  • Full-time
  • 2 days ago
  • Apply easily
Responsibilities:
  • Lead Quality Engineering activities in new product development (design control, risk management, verification/validation).
  • Develop and maintain the Risk Management File (RMF) and Design History File (DHF).
  • Provide statistical guidance for design verification, validation, and test method validation.
  • Act as SME for software quality, including code reviews, software security, and BOM management.
  • Support product design transfer, production, and remediation of anomalies (bugs, cybersecurity vulnerabilities).
  • Drive Quality System updates, CAPA resolution, and quality support for released products.
Requirements:
  • B.S./M.S. in Biomedical, Software, Electrical Engineering, or related field.
  • 8+ years of progressive Quality Engineering experience in the medical device industry (hardware and software).
  • Strong knowledge of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366.
  • Proven expertise in design, development, verification, validation, and testing of medical devices.
  • Skilled in statistical tools, quality engineering methods, and data analysis.
  • Excellent communication, problem-solving, and project management skills.
  • ASQ CQE, Six Sigma Black/Green Belt, experience with SaMD, AI/ML, AAMI TIR45, and cloud-based infrastructures.

cGxPServe