About Us We''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 Responsibilities Support FDA and CE Mark regulatory submissions and ongoing compliance activities Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards Prepare for and participate in internal and external audits, including FDA inspections and Notified Body assessments Review and approve quality documentation, including DHFs, DMRs, and technical files Investigate non-conformances and support CAPA processes Provide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirements Conduct supplier audits and manage vendor quality performance Support design control activities and product development projects Drive continuous improvement initiatives across the quality function Essential Experience Proven experience in a QA role within the ..... full job details .....