Jobs at Countable Labs

Lead and build the company quality function and QMS from development through early manufacturing and commercialization. Own design control, DHF, CAPA, change control, supplier/CDMO qualification, incoming/in-process/final quality, audits, training, KPIs, risk management (FMEA), post-market surveillance, and cross-functional quality governance to ensure regulatory readiness for future IVD products.

Own product strategy and roadmap for the Countable PCR platform, driving instrument, software, reagent and assay development through launch and lifecycle. Lead voice-of-customer research, pricing/forecasting, GTM positioning, sales enablement, field training, and technical content for CGT and oncology markets. Collaborate cross-functionally with R&D, commercial, operations, and executives; travel 10–20% for partners and conferences.