Stuart R. is a Project Engineer and Principal Consultant at Validant. He possess expertise in six sigma, quality management, design control, supplier quality management, 21 cfr and 45 more skills. He is proficient in French. Colleagues describe him as "I had the genuine pleasure of working with Stuart Roberts on two projects during the summer and fall of 2022 at Innova Medical Group. Stuart’s immediate knowledge of diverse EU and FDA regulations for medical devices was extremely helpful as we established a thorough design and development plan and complicated design requirements for a novel diagnostic test which incorporated unique design elements previously absent from all existing IDV technologies. Stuart also possesses a strong command of the risk management process for medical devices which he skillfully demonstrated as we worked together to prepare hazards analysis documents and comprehensive failure mode effects analysis deliverables for design, use, and process. Perhaps the attribute of Stuart that I most appreciated though, was his exceptional collegial and professional demeanor. I would always look forward to my interactions with Stuart because he was consistently friendly, patient, helpful, and cooperative. I hope that I can have the opportunity to work with Stuart in the future." and "I had the privilege of working with Stuart Roberts on a project at Innova Medical Group (IMG) during the time IMG was under a 483/warning letter and in the process of developing a Quality Management System. Stuart was the subject matter expert on Design Controls and Risk Management but was very knowledgeable in the medical device industry and all areas of the Quality System and Operations. He developed procedures, work instructions for Design Controls and Risk management and implemented them in the remediation of the Design History Files for the product as well as drove couple of New Product Development projects through the Design Controls phase gate milestone process.
Stuart was also instrumental in moving the entire Design History Files also with Risk and Clinical files that were paper based into TrackWise Digital. Stuart is proactive, results oriented with a high sense of urgency and always has a “can-do” attitude inspiring and coaching his team members to succeed. He is a great communicator, team player who collaborates cross functionally with all the stakeholders to get the job done. His knowledge of Design Controls, Risk coupled with knowledge of regulatory requirements helped meet FDAs 483 commitment deadlines, notified body deadlines and distribute product globally.
I highly recommend Stuart and he would be a great asset to any organization and I hope I get a chance to collaborate with him again in the future."
Listed skills include Six Sigma, Quality Management, Design Control, Supplier Quality Management, and 46 others.
