Product Design Quality Engineer

**Summary :** This is a Product Design Quality / Design Quality Engineering role in the medical device / regulated product domain. The engineer will support the complete product lifecycle, especially Design Control, Design Verification \& Validation (V\&V), Risk Management, CAPA, RCA, Process Validation, PMS, and regulatory compliance. **Roles \& Responsibilities :** * Manage the Design Control process from design inputs through verification, validation, and design transfer. * Develop and execute process validation strategies using statistical/data\-analysis methods. * Prepare and maintain Quality Plans and other quality engineering documentation. * Perform Design Verification (DV) and Design Validation (PV) planning and support execution. * Review product/system designs for quality, reliability, safety, performance, and manufacturability. * Perform Root Cause Analysis (RCA) for product and quality issues. * Manage CAPA activities, including investigation, corrective action, and effectiveness checks. * Support Risk Management/Risk Assessment throughout the product lifecycle. * Use Post\-Market Surveillance (PMS) data to identify product quality issues and improvement opportunities. * Work with R\&D, Manufacturing, Regulatory, Quality, and external stakeholders. **Experience \& Experience:** * Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent. * Six Sigma Green Belt certification is preferred. * Master's degree: No prior experience is specified as mandatory. * Preferred experience includes Design Control, Design Verification \& Validation (DV/V), Process Validation, Risk Management, CAPA, RCA, PMS, and medical\-device/regulatory quality.