Job Title: Senior Quality Engineer This is a pivotal role in the Growth Phase of our company, where we are preparing to commercialize a novel product and build out operational infrastructure for rapid scaling. As a primary quality liaison with contract manufacturing partners, you will have direct influence on product quality, efficiency, and global regulatory compliance. The successful candidate will possess deep expertise in Operations Quality and New Product Introduction (NPI), with experience managing complex compliance requirements across multiple external vendors. This includes serving as the core quality contact assessing contractor processes and systems meeting all quality controls, ensuring comprehensive compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971, (Risk Management). Your responsibilities include developing process validation (