Director Quality Engineering

Location: Remote
Compensation: Salary
Staff Reviewed: Wed, Feb 07, 2024
This job expires in: 9 days

Job Summary

A company is looking for a Director of Quality Engineering.

Key Responsibilities:
  • Optimize and clarify system architecture standards for verification and validation testing
  • Lead the development of V&V protocols and reports for new technologies
  • Represent the company as a Design Control expert in audits and support cross-functional programs

Required Qualifications:
  • Direct experience with SaMD Design Verification and Validation processes
  • Experience with software as a medical device, preferably AI/ML-based
  • Expertise in selecting design validation methodologies and statistical justification
  • Experience with software change control, risk assessment, and regulatory reporting
  • Bachelor's degree required, Master's degree preferred in a technical discipline

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