This role serves as the single Operations Quality point of contact for manufacturing quality systems and supplier quality engineering support, ensuring prototype, pilot, clinical, and early commercial builds are compliant, well-controlled, and supported by capable suppliers, inspection strategies, and scalable quality processes. Ideal candidates will bring expertise in quality engineering, supplier quality, FDA/ISO 13485 compliance, and NPI programs, along with a passion for leadership, problem-solving, and building robust quality systems that support successful product launches.