Senior Operations Manager

EKF Diagnostics is seeking a full-time Senior Operations Manager based in Boerne, Texas to lead and optimise the production, manufacturing, and logistics operations for clinical diagnostic products.

Key responsibilities include overseeing production planning (assemblies, reagents, packaging), managing purchasing, shipping and warehousing, ensuring compliance with FDA, ISO and MDSAP standards, developing SOPs, driving continuous improvement, and leading cross-functional teams. You’ll also be accountable for KPIs, root-cause analyses, quality events (e.g. CAPA/NCR), and supply-chain planning.

Candidates should have extensive leadership experience in medical technology, direct management experience (3+ years), in-vitro diagnostics and cGMP manufacturing background, and strong knowledge of ISO 9001, ISO 13485, and 21 CFR Part 820. Experience with ERP or WMS systems is required; a Bachelor’s degree or equivalent is preferred.

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