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.