Responsibilities: Partner with development teams to ensure compliance with FDA, ISO , IEC , ISO , and cybersecurity standards.

Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls.

Lead software risk management (RMF), including risk evaluation, control, and mitigation.

Drive Secure Product Development Framework (SPDF) and software security best practices.

Support Agile software development teams, ensuring regulatory and quality compliance.

Own and resolve CAPAs related to design control and software quality processes. Requirements: + years in medical device software quality engineering.

Deep knowledge of CFR , ISO , IEC , IEC , AAMI TIR, ISO , IEC , and cybersecurity standards.

Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management.

Hands-on experience with design control documentation, risk management, and DHF oversight.

Proficiency in Microsoft Office, Azure DevOps, statistical tools (, Minitab), and vulnerability scanning.

Preferred: ASQ CQE, Six Sigma Black Belt/Green Belt, ISO/IEC , cloud infrastructure expertise.