Description

Key Responsibilities
 • Owning software quality governance across the SDLC, ensuring readiness from requirements through V&V and release for IDE and PMA
• Reviewing and challenging existing SOPs and quality processes to identify gaps, inconsistencies, or misalignment with regulatory expectations
• Ensuring end to end traceability across user needs, requirements, risk controls, and verification/validation activities
• Governing software design controls and ensuring completeness and audit readiness of DHF deliverables
• Supporting IDE clinical study readiness including configuration management, version control, and change impact assessments
• Overseeing risk based software V&V activities and ensuring validation evidence is complete and defensible for regulatory submissions
• Collaborating cross functionally (software, systems, regulatory) to ensure quality requirements are defined and met
• Supporting PMA submissions, audits, and FDA interactions by providing software quality documentation and SMEs support

What are the Mandatory skills and skill proficiencies required for this position?
• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
• Hands on experience with software verification and validation using risk based approaches aligned with FDA expectations
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)
• Experience with test management, defect tracking, and quality documentation tools
• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions

Key Skills

Education

Any Gradute