Jobs at EKF Diagnostics Inc

Support regulatory compliance for medical devices/IVDs by preparing and maintaining registrations and submissions (e.g., 510(k)), managing UDI and documentation, assisting with adverse event reporting, coordinating with cross-functional teams, and ensuring adherence to standards (ISO, QMS, cGMP) and country-specific requirements.

Support and maintain the Quality Management System (QMS) for medical devices/IVDs: manage CAPAs, internal/external audits, document control, training, supplier qualification, batch release, risk management, trend analysis, and audit support to ensure regulatory compliance and inspection readiness.

Support day-to-day quality operations: batch record review and release, QC and environmental testing, instrument calibration, CAPA/NCR documentation, validation and document control support, data trending, audits, and ensure cGMP/QMS compliance in a manufacturing laboratory environment.

Provide technical leadership for microbial fermentation and downstream processing in a CMO/CDMO. Operate and maintain large-scale fermentation, chromatography, TFF, and lyophilization equipment; resolve process deviations; lead validation (IQ/OQ/PQ) and SOP revisions; ensure cGMP/ISO compliance and client-facing technical communication.

Support development, maintenance, and continuous improvement of the QMS aligned to ISO 13485/9001 and FDA QMSR. Lead/support CAPA, internal and external audits, training management, supplier qualification, batch review/release, documentation control, risk management, and reporting to ensure inspection readiness and compliance.