Responsibilities: Responsibility for industrialization and process validation of manufacturing and special processes (end-to-end) Planning and execution of IQ/OQ/PQ including validation strategy, protocols, evaluation and final reports Development and moderation of PFMEA including action planning, proof of effectiveness and ongoing maintenance Establishment of process capability studies (Cp/Cpk), SPC approaches and process windows for critical characteristics (CTQs) Definition and implementation of control plans, test plans, in-process controls and release criteria Management of ramp-up activities: line/plant capability, throughput, yield/FPY, bottleneck analysis, stabilization Interface management with production, quality, R&D, supply chain and external partners (CMOs/suppliers) Responsibility for process documentation: SOPs, work instructions, parameter lists, traceability, change documentation Support/leadership of root cause analyses and implementation of corrective/preventive actions (CAPA) Qualification of equipment and supplier processes (FAT/SAT, acceptance testing, process approvals, outsourcing management) Ensuring compliance with regulatory requirements (MDR/ISO 13485) during the production transfer, including the design transfer interface. Experience in dental/implant manufacturing or high-precision manufacturing (e.g., CIM/CNC/grinding/polishing) Profile Requirements: Completed technical studies (e.g. process engineering, mechanical engineering, medical technology, production engineering) or equivalent experience Several years of experience as a Process/Industrialization Engineer in a regulated environment (ideally MedTech) Demonstrable practice in IQ/OQ/PQ, statistical analysis and auditable documentation Experience with PFMEA, Control Plan, CTQ methodology and process capability analyses (Cp/Cpk, SPC) Hands-on mentality on the shop floor, but at the same time strong in documentation and compliance Structured, independent and goal-oriented work style Reliability, accuracy and a strong commitment to quality Excellent communication skills (German & English)