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About REMATIQ REMATIQ is changing how MedTech teams develop, document, and launch medical devices by building a highly specialised AI platform for regulated R&D, quality, and regulatory workflows. We work with leading life sciences and MedTech companies to help them move faster while improving quality, traceability, and compliance. We are looking for an AI Deployment Strategist – MedTech Quality Management to help our customers transform complex quality and QMS workflows into practical AI-powered solutions. We believe in the value of in-person collaboration and work in a hybrid setup, with the team coming together in our office in the heart of Berlin-Mitte typically four days per week . What you’ll do As an AI Deployment Strategist – MedTech Quality Management at REMATIQ, you will work closely with customers, Delivery, Product, and Engineering to drive customer projects, understand how MedTech quality teams work today, and help translate their workflows into high-impact AI use cases. This is not an academic advisory role. You will be hands-on in customer projects, helping structure problems, drive workstreams, create materials, review outputs, and turn domain expertise into practical solutions. You will: Own and drive customer project workstreams from discovery through workflow design, implementation support, testing, iteration, and delivery. Work directly with Quality, Operations, R&D, Regulatory, and cross-functional customer teams to understand their QMS processes and documentation, including SOPs and work instructions, CAPA and nonconformance handling, complaints and post-market surveillance, change control, supplier quality, audit readiness, and related product-development records, as well as the constraints, pain points, and opportunities for AI-powered improvement. Bring deep MedTech quality management expertise across areas such as ISO 13485, FDA QMSR / 21 CFR Part 820, MDSAP, ISO 14971 risk management, design controls, CAPA, deviations, supplier quality, and internal and external audits — and act as a domain sparring partner for internal teams. Create and review project deliverables such as customer workshop materials, process and workflow maps, QMS and standards gap analyses, impact assessments, target process designs, use-case specifications, and AI-generated outputs together with customer subject-matter experts. Collect customer learnings and feedback and translate them into structured internal feedback for Product and Engineering. Use AI tools actively to speed up your own work, create high-quality outputs faster, and improve how customer projects are delivered. What we’re looking for We are looking for someone who combines deep MedTech quality management expertise, strong project ownership, customer-facing communication, and a hands-on execution mindset. You may be a strong fit if you have: 5–8 years of relevant experience in MedTech quality management, QA/QM, QMS ownership, quality systems, quality operations, or a related consulting role. Practical understanding of how a medical device QMS operates day to day , including areas such as document and change control, design controls, risk management, verification & validation, CAPA and nonconformance handling, complaints and post-market surveillance, supplier quality, training and competence, management review, and audits and inspections — and the ability to translate this expertise into AI-enabled use cases, project deliverables, and structured product feedback. Strong project ownership: you can structure ambiguous work, align stakeholders, manage risks, define next steps, and drive cross-functional customer projects from problem understanding to delivery. Strong customer-facing communication: you can build trust with Quality, Regulatory, Operations, R&D, and senior stakeholders, ask sharp questions, and explain complex topics clearly.

AI Deployment Strategist – MedTech Quality Management

No apliques sin prepararte

AI Deployment Strategist – MedTech Quality Management

No apliques sin prepararte