AI Deployment Strategist – MedTech Quality Management

Meyandy LLC; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

REMATIQ in Berlin-Mitte seeks an AI Deployment Strategist – MedTech Quality Management to drive client projects from discovery to delivery. You will engage with Quality, Regulatory, and Operations teams to map QMS processes and design AI-powered improvements in regulated environments.

You will bring deep MedTech QMS know-how across ISO13485, FDA QMSR/21 CFR Part 820, MDSAP, and risk management, translating insights into actionable use cases and high‑quality deliverables.

Qualifikationen

• 5–8 years of MedTech quality management experience.
• Understanding of QMS operations including design controls, risk management, verification & validation, CAPA, post‑market surveillance, supplier quality, audits.
• Ability to translate QA expertise into AI-enabled use cases, project deliverables, and structured product feedback.
• Strong project ownership: ability to structure ambiguous work, align stakeholders, manage risks, and drive delivery.
• Strong customer-facing communication with Quality, Regulatory, Operations, R&D, and senior stakeholders.

Aufgaben

• Own and drive customer project workstreams from discovery through workflow design, implementation support, testing, iteration, and delivery.
• Work with Quality, Operations, R&D, Regulatory, and cross‑functional customer teams to map QMS processes and documentation.
• Create and review project deliverables such as workshop materials, process maps, gap analyses, and AI-generated outputs with subject‑matter experts.
• Collect customer learnings and translate them into internal feedback for Product and Engineering.
• Use AI tools to speed up work and improve how projects are delivered.

Kenntnisse

Quality management

Project ownership

Stakeholder communication

MedTech QMS knowledge

Regulatory compliance

AI-enabled workflows

Tools

ISO13485

FDA QMSR / 21CFR Part 820

MDSAP

ISO14971

CAPA

Audits

Jobbeschreibung

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

• 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 ISO13485, FDA QMSR / 21CFRPart820, MDSAP, ISO14971 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

• 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.
• Hands‑on execution mindset: you are comfortable creating…

Location

Berlin. Hybrid: in the office in Berlin‑Mitte four days per week.