We are seeking a dedicated QMS Lead (m/f/d) to take responsibility for the design, harmonization, and implementation of our quality management system across the EMEA, NA, LA, and APAC regions. In this key role, you will ensure compliance with the highest international standards and act as a central interface between global strategies and local implementation. QMS Strategy & Design: Leading the development and implementation of the QMS, taking into account ISO 13485 (including TCP III), ICH Q10, MDR, and MDSAP (Class I and II medical devices). Project Management: Managing the entire QMS project lifecycle – from analysis and design through localization to coordination with Global and Local Process Owners (GPOs/LPOs). Change Management: Facilitating the Change Review Board (CRB) meetings, including preparation, documentation, and follow-up of actions. Audit Readiness: Ensuring audit readiness (Stage 1/2, internal/external audits) in collaboration with the Head of Quality Systems and coordinating CAPA measures. Risk management: Identification and minimization of risks regarding schedules, resources, and eQMS compliance; escalation management as needed. Interface management: Establishment of clear QMS interfaces with manufacturers (QAA) and coordination of technical requirements for software systems (e.g., eDMS, Polarion, Luminus).
- Professional experience: 3–5 years of sound experience in quality assurance or quality management for medical devices or pharmaceuticals.
- Industry expertise: At least 3 years of practical experience in the development, manufacture or testing of medical devices.
- Regulatory expertise: Confident handling of national authorities and third-party audits (e.g., EU Notified Bodies, US FDA).
- Systems affinity: Experience in working with eQMS/eDMS tools and their implementation in a regulated environment.
- Language skills: Fluent English skills, both spoken and written, are mandatory.
- Mobility: You have a moderate willingness to travel for occasional international assignments.