Quality and Regulatory Partnership: Partner closely with Quality and Regulatory Affairs to maintain compliance with applicable FDA requirements, the FDA Quality Management System • Regulation (QMSR), ISO 13485, combination-product requirements including 21 CFR Part 4, and applicable cleanroom and environmental-monitoring requirements.• Cross-Functional Collaboration: Work closely with Quality, Regulatory, Engineering, Supply Chain, Procurement, Finance, R&D, and other functions to support site readiness, product transfers, production planning, new-product introduction, and business objectives.