Staff Design Quality Engineer

What you'll do: Own Design History Files and design control across multiple assay, consumable and instrument programs Lead ISO 14971 risk management, including hazard analysis, design/process/use FMEAs, and risk control verification Select, implement and administer the company's electronic QMSRun CAPA, nonconformance and deviation management end to end, from root cause to effectiveness checks Qualify and monitor suppliers, CDMOs and OEM partners, including incoming inspection and supplier corrective actions Lead process validation (IQ/OQ/PQ) and support assay, instrument and software validation Build the internal audit program and drive toward ISO 13485 certification and IVDR readiness What you'll bring 8-10+ years of quality experience within IVD product development and commercialization Experience building or substantially rebuilding a quality system, not just operating within one Ownership of a Design History File for at least one product from concept to design transfer or launch Working command of 21 CFR 820 (QMSR), ISO 13485, ISO 14971 and cGMPStrong applied statistics: sampling plans, process capability, gage R&R, method validation and DOEASQ CQE certification or equivalent Enough technical depth in molecular, assay chemistry or instrumentation to credibly challenge data

Bonus: IEC 62304 and premarket cybersecurity experience