Quality Systems and Compliance Lead (MedTech)

TL;DR

Quality Systems and Compliance Lead (MedTech): Driving quality excellence and regulatory compliance for AI-enabled precision health solutions with an accent on QMS implementation and medical device software lifecycle management. Focus on leading cross-functional quality initiatives, ensuring conformance with ISO 13485 and FDA standards, and advancing quality oversight for AI/ML and generative AI products.

Location: Must be based in Dallas, Texas

Salary: $142,000 - $213,000

Company

hirify.global is a data platform and technology company building AI-enabled precision health solutions to improve research and care.

What you will do

• Lead the vision and implementation of the Quality Management System (QMS) across consumer, research, and medical device domains.
• Develop quality oversight frameworks for AI/ML and generative AI products, ensuring alignment with emerging regulatory guidance.
• Analyze quality metrics and performance data to drive continuous improvement and implement effective CAPA.
• Staff and develop a high-performing QA team, fostering an inclusive and accountable environment.
• Partner with engineering and product teams to embed quality practices into software development workflows.
• Maintain ISO 13485:2016 certification and lead expansion to additional certifications like MDSAP.

Requirements

• Bachelor's degree in a scientific or engineering field with 8+ years of experience in quality assurance or regulatory affairs.
• Must not require employer-sponsored work authorization now or in the future for employment in the United States.
• Proven experience managing a QMS in conformance with ISO 13485:2016 and FDA QMSR.
• Hands-on experience with design and development, CAPA, risk management (ISO 14971), and medical device software lifecycle (IEC 62304).
• Experience supporting or managing quality across SaMD and/or AI/ML-enabled products.
• Ability to lead cross-functional initiatives and influence stakeholders across engineering and clinical organizations.

Nice to have

• Advanced degree (MS, MPH, PhD) or quality certifications such as ASQ CQE, CQA, or RAC.
• Experience with MDSAP audit programs or leading successful ISO 13485 certification audits.
• Familiarity with FDA's predetermined change control plan (PCCP) guidance.
• Experience supporting quality across GCP and/or GCLP environments.
• Proficiency with Jira and GitHub for change control and design file management.

Culture & Benefits

• Competitive base salary with bonus and equity components.
• Comprehensive benefits package.
• Opportunity to work at the intersection of AI, data science, and healthcare.
• Commitment to an inclusive and equal opportunity work environment.