Sr. Manager / Associate Director, Quality Events (IVD)

Location: Fremont, California. Hybrid: onsite Monday and Tuesday, plus additional days as needed.

Salary: $165,000–$210,000 per year, plus performance-based bonus or sales incentive plan, long-term incentive units, and benefits.

Company

hirify.global develops personalized cancer testing using tumor-and-normal profiling, proprietary algorithms, genomic profiling, and assays for minimal residual disease, recurrence detection, targeted therapy selection, and biomarker strategy.

What you will do

• Own governance of global Nonconformance, Planned Deviation, CAPA, and Quality Investigation systems.
• Chair the cross-functional CAPA and Quality Review Board, directing root-cause analysis, risk prioritization, containment, and resolution.
• Establish KPIs, SLAs, dashboards, and management-review metric packs covering quality-event lifecycle performance and systemic risk.
• Lead eQMS optimization and continuous-improvement initiatives across Clinical Laboratory Operations, R&D, Assay Development, Manufacturing, and Supply Chain.
• Drive training on root-cause analysis, investigation technical writing, and risk evaluation.
• Represent quality-event programs during FDA inspections, Notified Body audits, and CLIA/CAP surveys, while ensuring audit readiness.

Requirements

• 8–10+ years of progressive Quality Assurance or Quality Systems experience in an FDA-regulated IVD, medical device, and/or clinical laboratory environment, including 4+ years in formal program management or supervisory/leadership capacity.
• Strong command of 21 CFR Part 820, ISO 13485:2016, and ISO 14971.
• Experience configuring, optimizing, and administering enterprise eQMS platforms such as ComplianceQuest, Veeva Vault, MasterControl, TrackWise, or Qualio.
• Proven success defending CAPA, Deviation, and Nonconformance files before FDA investigators and ISO/Notified Body auditors.
• Exceptional communication, data visualization, and technical writing skills, with the ability to influence cross-functional leaders without direct authority.
• Ability to manage multiple priorities and meet agreed timelines.

Nice to have

• Working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746).

Culture & Benefits

• Full-time regular employment with medical, financial, and other benefits.
• Annual performance-based bonus or sales incentive plan and long-term incentive units.
• Medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick and vacation time, commuter benefits, EV charging stations, onsite gym, and wellness benefits.
• Equal opportunity employer committed to reasonable accommodations and inclusion.