Project Manager eQMS - Medical Devices (w/m/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 at 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.

Volume: Full-time

Start: ASAP

SThree_Germany is acting as an Employment Business in relation to this vacancy.