Quality Systems and Compliance Lead (AI/ML & SaMD)

Location: Dallas, Texas, United States

Salary: $142,000–$213,000 base salary per year, plus bonus, equity, and benefits.

Company

hirify.global Health is a data platform and technology company developing AI-enabled precision health solutions from multimodal health data.

What you will do

• Lead the vision, implementation, and continuous improvement of the Quality Management System across consumer health, research, medical device, SaMD, and AI/ML products.
• Direct quality planning and oversight for medical device, research, commercial, AI/ML, and generative AI programs.
• Develop quality frameworks for AI/ML products, including model validation, monitoring, algorithmic change protocols, and regulatory alignment.
• Maintain ISO 13485:2016 certification and support expansion to additional certifications such as MDSAP.
• Analyze quality metrics, lead CAPA and risk-management activities, and drive continuous improvement.
• Build, coach, and develop QA teams while partnering with engineering, product, clinical, and operations stakeholders.

Requirements

• Bachelor’s degree in a scientific, engineering, or related field and 8+ years of quality assurance or regulatory affairs experience in medical devices, digital health, or life sciences.
• Experience leading or managing a QMS aligned with ISO 13485:2016 and FDA QMSR across multiple product domains.
• Hands-on knowledge of design and development, CAPA, ISO 14971 risk management, and IEC 62304 medical device software lifecycle processes.
• Experience supporting quality for SaMD or AI/ML-enabled products and knowledge of applicable FDA and international regulatory frameworks.
• Experience leading cross-functional initiatives and managing or developing QA teams.
• Must not require employer-sponsored work authorization now or in the future for employment in the United States.

Nice to have

• Experience with MDSAP programs or ISO 13485 certification and surveillance audits.
• Knowledge of FDA predetermined change control plan guidance and IMDRF harmonization efforts.
• Experience with GCP or GCLP environments, clinical research, or laboratory programs.
• Experience with Google Workspace, Jira, and GitHub for quality and software development processes.
• Advanced degree or quality certification such as ASQ CQE, CQA, or RAC.

Culture & Benefits

• Cross-functional collaboration across engineering, product, clinical, research, and operations teams.
• Focus on quality awareness, GxP training, compliance, and embedding quality practices into software development workflows.
• Bonus, equity, and benefits are provided in addition to base salary.