Sr Quality Engineer

Overview

Sr Quality Engineer role at Katalyst CRO

• 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.

• 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 TIR
  45, and cloud-based infrastructures.

• Mid-Senior level

• Contract

• Quality Assurance
• Industries:
  Pharmaceutical Manufacturing

Location:

Bellevue, WA

Salary: $-$