About UsWe''re a working with an exciting MedTech company dedicated to advancing orthopaedic care through innovative medical device solutions. Their products improve patient outcomes and quality of life, and we''re looking for a talented QA Engineer to help us maintain the highest standards of quality and regulatory compliance.As a QA Engineer, you''ll play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You''ll work closely with RandD, manufacturing, and regulatory teams to maintain our Quality Management System and support our growing portfolio of cutting-edge medical devices.Key ResponsibilitiesSupport FDA and CE Mark regulatory submissions and ongoing compliance activitiesMaintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standardsPrepare for and participate in internal and external audits, including FDA inspections and Notified Body assessmentsReview and approve quality documentation, including DHFs, DMRs, and technical filesInvestigate non-conformances and support CAPA processesProvide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirementsConduct supplier audits and manage vendor quality performanceSupport design control activities and product development projectsDrive continuous improvement initiatives across the quality functionEssential ExperienceProven experience in a QA role within the medical device ..... full job details .....