Head of Quality and Regulatory (Medical Devices)

Location: Bay Area, onsite role; South San Francisco, California

Company

hirify.global is a medical diagnostics company developing the IntelliSep sepsis detection assay, which analyzes white blood cell structure from a standard blood draw and produces results in less than 10 minutes.

What you will do

• Own the Quality Management System and serve as the designated Management Representative.
• Define quality strategy, objectives, KPIs, and quality infrastructure, including eQMS evolution and AI-enabled quality processes.
• Lead Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and audit programs.
• Direct design quality, process validation, change management, supplier quality, manufacturing quality, and product improvement activities.
• Partner with Regulatory Affairs on an 18–24-month roadmap covering letters to file, Special and Traditional 510(k)s, and PCCPs.
• Lead post-market surveillance, complaints, investigations, CAPA, MDR and vigilance reporting, FDA inspections, Notified Body audits, and third-party registrations.

Requirements

• Bachelor’s degree in an engineering discipline.
• 10+ years of progressive quality leadership in the medical device or IVD industry, including 7+ years managing quality teams and organizational performance.
• Experience leading QA/RA functions at a small- to mid-sized Class II device company and improving on-market products.
• Deep knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, cGMP, and IVD-specific regulatory and quality requirements.
• Experience leading FDA inspections and Notified Body audits, sustaining inspection readiness, and managing Quality Assurance and Quality Control organizations.
• Expertise in risk analysis, FMEA, statistical methods, process and software validation, test method validation, measurement systems analysis, structured problem solving, and corrective actions.

Nice to have

• MBA or master’s degree in engineering or a related field.
• Hands-on experience with eQMS platforms and AI-enabled quality tools.
• Six Sigma Green Belt or Black Belt certification.
• ISO 13485 Certified Internal Auditor or comparable ASQ certification such as CQA, CQE, or CMQ/OE.

Culture & Benefits

• Hands-on leadership and cross-functional partnership across Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and R&D.
• Focus on continuous improvement, data- and risk-based decision-making, accountability, and organizational quality ownership.
• Opportunity to build and develop a high-performing team of quality engineers, quality professionals, and future quality leaders.