Staff Quality Engineer (IVD)

Location: San Diego, United States; on-site

Salary: $125,000–$160,000 annually, depending on experience and qualifications.

Company

hirify.global is an early-stage biotechnology company developing genomics and molecular detection platforms that integrate molecular biology, chemistry, and systems engineering.

What you will do

• Build, administer, and continuously improve the quality management system for a 30–50 person organization.
• Own Design History Files and design control across molecular assay, consumables, and instrument programs from concept through design transfer.
• Lead ISO 14971 risk management, including hazard analysis, FMEA, risk-control verification, and benefit-risk rationale.
• Manage CAPA, nonconformances, deviations, investigations, effectiveness checks, trending, and management-review inputs.
• Qualify and monitor suppliers, CDMO partners, and OEM chemistry sources, including incoming inspection and supplier corrective actions.
• Lead process validation using IQ/OQ/PQ and applied statistics, and support assay, instrument, software, and computer system validation.

Requirements

• 10+ years of quality experience in medical device or IVD product development and commercialization.
• Working command of FDA QMSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, ISO 14971, and cGMP.
• ASQ Certified Quality Engineer certification or equivalent.
• Applied statistics experience covering sampling plans, process capability, gage R&R, method validation, and DOE.
• Hands-on experience building or substantially rebuilding quality systems and owning a Design History File through design transfer or launch.
• Technical depth in molecular/genomics, assay chemistry, or instrumentation, with the independence to challenge engineering, R&D, and executive stakeholders.

Nice to have

• Familiarity with IEC 62304.
• Experience with premarket cybersecurity documentation.

Culture & Benefits

• Collaborative, cross-functional, R&D-driven environment.
• Early-stage opportunity to shape quality infrastructure, procedures, and company practices.
• Medical, dental, and vision coverage.
• Company-paid life insurance and a 401(k) retirement plan.
• Generous paid time off plus voluntary benefits, employee perks, and discount programs.