Senior Quality Engineer (AI/ML Medical Devices)

Location: Remote - US Only; current, unrestricted authorization to work in the United States is required. Synchronous hours are 11a-5p ET (8a-2p PT).

Salary: $142,768–$161,901 annually, with a possible geographic premium for candidates in certain high-cost cities.

Company

hirify.global develops FDA-cleared, AI-driven clinical decision support software that integrates with Epic and Oracle Health workflows to help clinicians identify life-threatening conditions earlier.

What you will do

• Partner with engineering and data science across requirements, architecture reviews, software risk analysis, verification and validation, traceability, and release readiness.
• Maintain design history files, risk management files, quality procedures, document control, training records, and compliance evidence.
• Assess software and AI/ML model changes for regulatory impact and support letters-to-file, new submissions, and change control.
• Manage complaint intake, triage, investigation, MDR reportability assessments, trend analysis, nonconformance reports, and CAPAs.
• Contribute to 510(k)s, Q-Submissions, Predetermined Change Control Plans, FDA responses, and FDA inspection readiness.
• Translate FDA AI/ML, cybersecurity, and quality system expectations into product requirements and operational procedures.

Requirements

• BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical field, or equivalent practical experience.
• 5+ years of software quality, design quality engineering, or regulatory experience for software medical devices under ISO 13485 and IEC 62304.
• Hands-on ownership of design controls, ISO 14971 risk management files, complaint investigations, adverse-event reportability decisions under 21 CFR 803, trending, and CAPA.
• Experience writing and improving QMS procedures, document control, change management, and compliance records in a regulated software environment.
• Ability to read code, logs, and automated test results and investigate software issues independently in a cloud-based SaaS environment.
• Current, unrestricted authorization to work in the United States is required; visa sponsorship is not provided.

Nice to have

• Experience with AI/ML-enabled medical devices, algorithm change control, model performance monitoring, and FDA AI/ML guidance.
• Experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers.
• Familiarity with Epic, Oracle Health, SMART on FHIR, CDS Hooks, eQMS platforms, Jira-based defect tracking, and computerized system validation.
• Experience supporting FDA inspections, ISO 13485 certification audits, or customer audits.
• ASQ CQE/CSQE, RAC, or an equivalent quality or regulatory certification.

Culture & Benefits

• Remote collaboration with real-time synchronous work and an annual in-person company retreat.
• Medical, dental, and vision coverage, including an HSA-eligible option and One Medical access.
• Company-paid life and disability insurance, 401(k), generous PTO, paid sick time, and paid holidays.
• Mental health support, wellness resources, home office stipend, Mac hardware, and internet and phone reimbursement.
• Equity eligibility and a mission-driven environment focused on patient outcomes and clear communication.