Senior Quality Engineer

Responsibilities

• Technical project management for development projects (scope, timeline, budget, resources, risks, deliverables)
• Experience in the development/optimization of ceramic implants and leading interdisciplinary teams (R&D, QA, RA, production, purchasing, suppliers, external partners) including meeting moderation, decision gates and stakeholder reporting.
• Hands-on development of products/components: concept, design, prototyping, test planning and technical evaluation
• Responsibility for end-to-end design control (e.g., ISO 13485)
• Coordination of laboratory and testing activities (mechanics, fatigue strength, material/surface characterization, and, if necessary, biocompatibility in consultation)
• Support with root cause analyses and CAPA-related activities in collaboration with QA
• Experience with ISO 14971 (risk management), MDR/CE, and possibly FDA/21 CFR 820.
• CAD experience and technical understanding of tolerance management and manufacturing processes
• Experience in dental/implantology (compatibilities, interfaces, clinical requirements)

• Completed studies in mechanical engineering, medical technology, materials engineering, plastics/ceramics technology or similar.
• Several years of experience in product development (ideally Med Tech/Dental)
• Experience in project management (internal/external), including planning, control and stakeholder management
• Very good understanding of design control and technical documentation in a regulated environment (ISO 13485 / comparable)
• Experience with verification/validation, testing methods
• Structured, independent and goal-oriented work style
• Reliability, accuracy and a strong commitment to quality
• Strong communication skills (German & English)