Design Quality Engineer

We're hiring a hands-on Staff Quality Engineer to build a quality system from the ground up as assay, consumable and instrument programs move from concept through design transfer and commercialization. This is a true builder role. There's no existing quality team, so you'll write the procedures, train the team on them, audit against them, and refine what doesn't work.

• 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 QMS
• Run 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

• 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 cGMP
• Strong applied statistics: sampling plans, process capability, gage R&R, method validation and DOE
• ASQ CQE certification or equivalent
• Enough technical depth in molecular, assay chemistry or instrumentation to credibly challenge data
• Bonus: IEC 62304 and premarket cybersecurity experience