Sr. Quality Engineer (NPI)

Provide quality leadership and guidance throughout new product development, technology transfers, and product launch activities. Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable regulatory requirements. Participate as the Quality representative on cross-functional NPI and product development teams. Review and approve Design Control deliverables, including design plans, user requirements, specifications, verification and validation protocols, and design transfer documentation. Lead and facilitate risk management activities, including risk assessments, FMEA development, hazard analyses, and risk-control verification. Support manufacturing process development and validation activities, including IQ, OQ, PQ, MSA, and software validation where applicable. Collaborate with Manufacturing Engineering to ensure robust process controls and production readiness prior to product launch. Partner with Supplier Quality and Procurement teams to qualify and monitor suppliers supporting new product introductions. Review and approve validation protocols, engineering studies, and technical reports. Drive resolution of quality issues identified during development, validation, pilot builds, and commercialization phases. Support design transfer activities to manufacturing sites. Ensure appropriate quality metrics, inspections, and acceptance criteria are established for new products and processes. Support site continuous improvement projects as needed. Participate in internal and external audits and support regulatory inspections as required. Mentor and supervise engineers and provide technical leadership on quality and compliance-related initiatives.