R&D / Technical Develeopment Quality Lead

Are you passionate about quality and precision? Join our client in this RD, Quality Lead position and help ensure top-tier standards every day. Proclinical is seeking a Quality Assurance Lead to support and guide global projects within the medical device sector. In this role, you will provide quality oversight, lead cross-functional teams, and ensure compliance with regulatory standards. This position focuses on driving quality initiatives, supporting technical research and development, and contributing to the successful delivery of high-quality medical devices. Please note that to be considered for this role you must have the right to work in this location or hold an EU passport. Responsibilities: Lead and support global project teams, representing Quality Assurance (QA) in key meetings and decision-making forums. Provide quality oversight and guidance for assigned development projects, ensuring compliance with internal and external medical device requirements. Develop and align project strategies with organizational goals, including risk assessments and contingency planning. Act as the QA representative for technical documentation, ensuring quality standards are met. Collaborate with cross-functional teams to manage project-related activities and ensure seamless communication across departments. Support impact assessments and actions related to design and manufacturing changes for medical devices. Contribute to the creation and maintenance of Quality Management System (QMS) documentation, such as SOPs and work processes. Assist in preparing for and hosting Notified Body inspections. Approve QA agreements, project-specific amendments, and technical records in systems like Trackwise. Monitor and assess new regulations and standards, defining and tracking necessary actions. Manage project trackers and prepare materials for governance and management forums. Key Skills and Requirements: Strong understanding of quality standards and policies in medical device manufacturing and control. Experience with Notified Body inspections and regulatory compliance. Proven expertise in device development and/or Quality Assurance/Quality Control roles. Ability to lead interdisciplinary teams and contribute to matrix environments with strategic thinking and quality awareness. Proficiency in computer systems, including MS Office and document management tools, with a willingness to learn new systems. Fluent in English (oral and written); additional proficiency in a local language is a plus. Educational background in a relevant field, such as a Bachelor's or Master's degree in a related discipline. #J-18808-Ljbffr