Countable Labs
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Biotech
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.
