Quality Engineer | Design Quality/Design Assurance Engineer | Validation EngineerTechnical Skill Set and Experience:-Design Controls experience- EU MDR & EU IVDR-Verification & Validation (Process, Equipment, Test Method and Design V&V and wrote summaries and reports and dispositioned any deviations appropriately per internal and regulatory requirements).-QMS cleanup and implementation experience utilizing ISO 13485-Risk Management (Knowledge and implementation experience of ISO 14971RM plans, PHAs, FMEAsas risk management tools, handling NCMRs,CAPAs, and Root Cause Analysis-Tooling and Fixture Qualification (initiated documents and engineering change orders to release new tooling and fixtures).-DHF Remediation (Gap assessment, review design inputs for requirements, Review and re-execute Test methods, re-develop DV protocols)-Manufacturing experience (Lead quality engineer for injection molded products, audit activities, authored manufacturing procedures as well as updated existing and prints or drawings, creation and implementation of visual aids)Products and Devices: all classes and typesCardiovascular & endovascular stents and grafts, blood bags, chest drains, single and multi-lumen catheters as stent delivery systems, balloon forming, injection molding, cuvettes and rotary systems, ophthalmology devices, epipens and drug delivery injectors, laparoscopic ablation gun device tips, mild brain trauma device, nano fluidics, IVD devices, venous and arterial closure devices for both cardiovascular and neuro surgeries, electro mechanical devices such as mobile infusion pumps, skin/tissue devices, and worked with Artificial Womb/CHOP/FDA breakthrough technology.