Hiring for QA RA Manager with mininum 5 years of experience Required Attributes 5+ years in QA/RA within medical devices or IVD- Hands-on CDSCO submissions experience (Class B & C devices, MDR 2017)- Strong ISO 13485 QMS ownership and internal audit experience- Familiarity with EU IVDR (Technical Files, PER, Notified Body liaison) and/or WHO Prequalification is a strong plus- Experience with design controls, ISO 14971 risk management, and CAPA
● Strategic Process Transformation & Standardization○ Identify, standardize, and automate high-impact processes across GBS, ensuringalignment with enterprise goals and customer experience standards. Leverage bestpractices to create a cohesive, unified approach to operational excellence.● Portfolio Management & Prioritization○ Develop a portfolio of improvement projects that drive tangible cost savings,process efficiencies, and customer satisfaction.
Job Description :Check and confirm material availability for all WIP and planned projects.Conduct a meeting with production managers for previous day's performance and update today's production schedule.Review project wise Factory Orders (FOs) releases.Review project-wise material readiness and update shortage list.Coordinate with Buyers for prioritization of material procurement.Coordinate with key stakeholders - Design, Project Management, Procurement,