R&D / Technical Develeopment Quality Lead

ppAre you passionate about quality and precision? Join our client in this RD, Quality Lead position and help ensure top-tier standards every day. /p pProclinical 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. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities: /h3 ul liLead and support global project teams, representing Quality Assurance (QA) in key meetings and decision‑making forums. /li liProvide quality oversight and guidance for assigned development projects, ensuring compliance with internal and external medical device requirements. /li liDevelop and align project strategies with organizational goals, including risk assessments and contingency planning. /li liAct as the QA representative for technical documentation, ensuring quality standards are met. /li liCollaborate with cross‑functional teams to manage project‑related activities and ensure seamless communication across departments. /li liSupport impact assessments and actions related to design and manufacturing changes for medical devices. /li liContribute to the creation and maintenance of Quality Management System (QMS) documentation, such as SOPs and work processes. /li liAssist in preparing for and hosting Notified Body inspections. /li liApprove QA agreements, project‑specific amendments, and technical records in systems like Trackwise. /li liMonitor and assess new regulations and standards, defining and tracking necessary actions. /li liManage project trackers and prepare materials for governance and management forums. /li /ul h3Key Skills and Requirements: /h3 ul liStrong understanding of quality standards and policies in medical device manufacturing and control. /li liExperience with Notified Body inspections and regulatory compliance. /li liProven expertise in device development and/or Quality Assurance/Quality Control roles. /li liAbility to lead interdisciplinary teams and contribute to matrix environments with strategic thinking and quality awareness. /li liProficiency in computer systems, including MS Office and document management tools, with a willingness to learn new systems. /li liFluent in English (oral and written); additional proficiency in a local language is a plus. /li liEducational background in a relevant field, such as a Bachelor's or Master's degree in a related discipline. /li /ul pIf you are having difficulty in applying or if you have any questions, please contact bOlivier Worch /b at /p /p #J-18808-Ljbffr