Senior Director, Global Quality

Lead and develop the Global Quality Assurance organization, including QA, QC,Quality Systems, Document control and Regulatory/Compliance. Define and execute the global quality vision, strategy, and metrics to support company growth and regulatory compliance. Serve as the executive sponsor for global quality initiatives, including ISO13485 certification. Bachelor's degree or higher in a relevant scientific or engineering discipline (e.g., Molecular Biology, Analytical Chemistry, Chemical Engineering or related engineering discipline). Phd preferred. 15+ years of progressive quality assurance leadership experience in Life Sciences, Diagnostics, or related industries, with proven success in consumables and instrumentation. Formal training and certification in Quality Assurance management (e.g., Six Sigma, ASQ). Demonstrated success in establishing and managing effective QMS and Document Control systems in high-growth, complex organizations. Experience leading organizations through ISO9001 and ISO13485 certification. Deep understanding of Operations and R&D functions. Exceptional leadership, organizational development, and communication skills, with a proven ability to influence across all levels of the business. Ability to manage global quality assurance with consistency, objectivity, and cultural sensitivity. Oversee the continued development and governance of the company's Quality Management Systems (QMS, LIMS, GLP and Training). Ensure effective CAPA, NCR, RMA, and discrepancy reporting processes are in place and continuously improved. Establish and manage supplier quality, design quality, and process quality systems. Drive compliance with global standards (ISO, FDA, CE, UL, TUV and country-specific Safety Data Sheets) and lead product certification processes (e.g., 510(k)). Implement scalable systems and workflow automation to improve efficiency and compliance.