Project Manager eQMS (m,w,d) Spring projects are still coming in strong as one of my clients, leader in medical technology worldwide, needs a Project Manager for the area of eQuality Management Systems. Feel free to take a look the details for your consideration and get in touch! Tasks: Lead end‑to‑end projects for eQMS selection and implementation, from initial concept through system rollout and transition into operational use. Report project progress, risks, and status related to budget, resources, and timelines to senior stakeholders and steering committees. Gather, document, and prioritize user and business requirements for an eQMS solution, ensuring alignment with quality, regulatory, and operational needs. Conduct market analysis and vendor assessments for eQMS tools based on functional requirements, efficiency, cost considerations, and reference customer evaluations. Ensure vendor solutions meet predefined technical, quality, and regulatory requirements Define implementation activities, including the level of external supplier involvement, system acceptance criteria, and readiness milestones. Plan and oversee computerized system validation (CSV) activities in accordance with applicable guidance and industry best practices. Enable data‑driven quality decision‑making through effective system configuration, reporting, and analytics capabilities. Develop training materials and deliver foundational user training to support successful system adoption. Create comprehensive process and system documentation to enable a smooth handover from project mode into line organization and sustainable operations. Ensure compliance with applicable quality standards and regulatory frameworks, including ISO 13485, 21 CFR Part 11, GAMP 5, GxP principles, EU MDR, and MDSAP. Establish effective collaboration with corporate IT functions to ensure seamless integration Requisites: Master's degree in engineering, data management, information systems, or a comparable qualification. Minimum of ten years of hands‑on experience in the implementation, deployment, and operational use of QMS software solutions within the medical device industry Proven leadership experience in large, cross‑functional quality or digital transformation projects, ideally involving the implementation or optimization of QMS Strong familiarity with enterprise‑level QMS and quality‑supporting software solution. In‑depth knowledge of applicable medical device standards, guidelines, and regulations Solid project management skills and high level of customer and stakeholder orientation, with the ability to balance business needs, regulatory requirements, and quality objectives. Area: Baden-Württemberg, Germany (hybrid) Volume: Full-time Duration : 6 months ECM model ( Arbeitnehmerüberlassung ; with possibility of extension or takeover) Start: ASAP If you are interested, please apply with your current CV and relevant certifications. If this opportunity is not of interest to you, feel free to pass it on to someone from your network. Thank you for your consideration and have a great day, Charlotte Valentiner Principal Candidate Consultant - Life Sciences / SThree GmbH SThree_Germany is acting as an Employment Business in relation to this vacancy.