Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements. Review and approve design documentation including Verification Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports. Support risk management activities including planning, design clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting. Revise, review and approve verification and validation activities as required. Review and approve any required drawing updates, including design impact assessments. Review and approve any labeling updates, including design impact assessments. Apply statistical methods and designprocess excellence tools to support design engineering rationalesmemos as required. Provide leadership in all areas of the Quality System, including, but not limited to corrective preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions. Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing. Strong designquality engineering skills with a proven track record in all aspects of the design control process, including functionaldesign requirements, design verificationvalidation, and product risk management are required. Proven track record implementing Quality System improvements to meet compliance and overall business goals. Change control experience (reviewing and approving design engineering change orders through a PLM System) is required Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 9342EEC, ISO13485 and ISO14971 quality requirements is preferred. Previous Quality Engineering experience is preferred.