Technical Supplier Manager: Manufacturing Transfer Engineer/Process Design / Industrialization / DFX / Process Design/ Stewardship / Project Governance Operations Support / statistical process control (SPC)/ capability studies (Cpk) / measurement systems analysis / English / Deutsch Background: The Perfect Candidate possesses a relevant technical degree and demonstrated expertise in statistical process control and project leadership, specifically in external technology transfers and line ramp-ups. Additionally, strong knowledge of precision manufacturing technologies and production cost optimization is required. Tasks Responsibilities: Manufacturing Process Design Industrialization (Core Activity) Process Architecture Development: Actively design, optimize, and industrialize robust manufacturing and testing processes for instrument components, electronics, and precision assemblies across the external supply base Process Capability Validation: Define process validation strategies (IQ/OQ/PQ), design verification protocols, and establish process capability baselines (Cp/Cpk analysis, tolerance studies, and Gage RR) Design for Excellence (DfX): Partner closely with RD during early product development to embed Design for Manufacturing, Assembly, and Testability principles into component designs, preventing manufacturing bottlenecks and driving yield optimization Process Risk Mitigation: Lead process failure mode and effects analysis (pFMEA), establish poka-yoke (error-proofing) controls, and drive root-cause investigations to engineer out process vulnerabilities Technical Project Leadership External-to-External (E2E) Transfers Lead Technology Transfers: Steer end-to-end technical transfers between external contract manufacturers and suppliers (External-to-External), including production line relocations, tool duplications, and second-source qualifications Project Governance Milestones: Establish qualification master plans (QMPs), define project schedules, align critical milestones, and report progress transparently to cross-functional leadership within MSAT and GIN Cross-Partner Synchronization: Lead technical alignment and change control across originating sites, receiving supplier facilities, Global Sourcing, Quality Assurance, and Regulatory Affairs Technical Supplier Stewardship Operations Support Supplier Performance Monitoring: Monitor supplier process stability, technical KPIs, and component quality trends across the complete instrument lifecycle Deviation Handling SCARs: Lead technical problem-solving teams (8D, Ishikawa, 5-Why) for component deviations; resolve Supplier Corrective Action Requests sustainably Supplier Technical Assessments: Conduct technical evaluations and audits of potential and existing suppliers as part of the formal supplier qualification process Operations Projects: Steer supplier-side engineering changes (without spec change), capacity expansions, and continuous line stabilization initiatives Must Haves: A University degree (Bachelor's, Master's, or Higher Technical Diploma) in Mechanical Engineering, Electrical Engineering, Mechatronics, Process Engineering, Industrial Engineering, or a related technical field At least 5–6+ years of relevant industry experience in manufacturing process design, technical supplier management, industrialization, or manufacturing engineering, ideally within medical devices, in-vitro diagnostics (IVD), pharmaceuticals, or precision high-tech equipment Process Design Expertise: Proven hands‑on track record in designing, qualifying, and optimizing manufacturing and test processes. Strong command of statistical process control (SPC), capability studies (Cpk), measurement systems analysis (MSA), and pFMEA Technical Project Leadership: Demonstrated leadership in complex technical projects, specifically external-to-external technology transfers, second-sourcing initiatives, or major line ramp-ups. Formal PM certification (PMP, IPMA, Agile) is an asset Manufacturing Technologies: Deep technical understanding of precision manufacturing technologies (e.g., injection molding, precision mechanics/machining, electronics assembly, automated testing) along with an understanding of production cost drivers and cycle time optimization Regulatory Quality Standards: Practical knowledge of ISO 13485, GMP/FDA regulations, process validation frameworks (IQ/OQ/PQ), and formal change management procedures Mindset Communication: Pragmatic, innovative problem solver with a "think-out-of-the-box" attitude and strong intercultural stakeholder management and communication skills Languages Mobility: Professional fluency in English and German (written and spoken). Willingness to travel globally (approx. 20–30%) for supplier on-site process reviews, audits, and transfer milestones
Technical Supplier Manager-925374 in Zug Arbeitgeber: ITech Consult
Roche ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, in einem dynamischen und innovativen Umfeld zu arbeiten. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung fördert Roche eine Kultur des Lernens und der Zusammenarbeit, in der kreative Ideen geschätzt werden. Die Position des Global Sites Network Communications Manager ermöglicht es Ihnen, einen bedeutenden Einfluss auf die Kommunikationsstrategien im Gesundheitswesen auszuüben und Teil eines engagierten Teams zu sein, das sich leidenschaftlich für die Verbesserung der Patientenversorgung einsetzt.