Director Quality Engineering

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