Npi Quality Engineer Ii
Current• Supported integration of Gen 2 product transfer from NPD site to production site, ensuring seamless scale-up and implementation • Drafted and executed IQ, TFIQ, and TMV protocols to validate equipment and processes • Set up and optimized new equipment and fixtures on the production line to improve efficiency and quality • Ensured compliance with ISO 13485 standards throughout all phases of product transfer and manufacturing • Collaborated cross-functionally with NPD, NPI, sustaining engineers, production teams, and operations to meet project objectives • Prepared and delivered reports to stakeholders, providing updates on progress, risks, and resolutions