Job
- Level
- Lead
- Job Feld
- Application, Project
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
- Ort
- Frankfurt am Main
- Arbeitsmodell
- Onsite
Job Zusammenfassung
In dieser Rolle führst du die technischen Aspekte des QMS-Arbeitsstroms und übernimmst Verantwortung für Architektur, Datenmigration und Sicherheitsstandards, während du eng mit globalen Prozessleitern zusammenarbeitest.
Deine Rolle im Team
- Own the technical backbone for your workstream.
- As the Technical Workstream Lead for a specific business workstream (e.g. Quality/QMS), you sit side-by-side with the Global Process Owner (GPO) and Global Process Leads (GPLs) to translate process design into robust and scalable technology across QMS.
- You lead the technical scope for your workstream - architecture, build, environments, integrations, data migration, non-functionals, security/compliance, releases, and hypercare - through stage gates to successful handover.
- You are the end-to-end technical owner of the QMS workstream.
- You co-lead the workstream together with the Business Workstream Lead/GPO, ensuring process-system alignment, decision-ready design, disciplined delivery, and operational readiness for your scope.
- Run technical governance for the workstream.
- Prepare decision-ready design packs and status for the Design Authority.
- Own the workstream technical RAID (Risks, Assumptions, Issues & Dependencies).
- Assess run-time/architecture risks, define mitigations, and escalate with clear options.
- Safeguard solution integrity against enterprise standards and non-functional requirements.
- Lead technical design for your workstream: integrations, extensions, data model, security roles, automation.
- Define and manage environments for the workstream: branching strategy, CI/CD pipelines, and code quality gates.
- Manage technical debt, versioning, and change control with impact analysis across upstream/downstream systems.
- Plan, prepare and execute migration tooling, trial loads, reconciliations/ validation, and cutover steps for your workstream objects.
- Ensure cybersecurity, privacy, Segregation of Duties (SoD), and validation/CSV compliance in collaboration with QA/Validation Lead.
- Coordinate internal platform teams and external vendors for your scope.
- Lead hypercare triage and stabilization for the workstream.
- Complete documentation and knowledge transfer to run.
- Partner daily with the GPO, GPLs, and Business Workstream Lead; align on scope, decisions, and adoption.
- Work with PMO on stage gates, quality reviews, plans, and dependencies to other workstreams.
- Participate in approved global projects.
- Provide advice for standard system and best practices of QMS and related systems.
- Act as Service Delivery Manager and Subject Matter Expert in QMS in the IT Application Team.
- Configure and maintain Ambu's QMS system, ensuring alignment with business requirements and best practices.
- Handle system configuration, unit testing, training, and documentation in accordance with standards in close cooperation with external partners.
- Manage Life Cycle Management & release management.
- Coach and review work performed by peer professionals.
- Work across functions and cultures to deliver high-quality global solutions.
- Work independently to solve complex problems.
- Train Business Process Owners and other key users.
- Follow regulatory compliance.
Unsere Erwartungen an dich
Qualifikationen
- Proven leadership of architecture, integrations (API/iPaaS), data migration, and release management within a defined scope.
- Strong command of non-functionals: performance, reliability, security, privacy, SoD, and validation/CSV.
- Adept at partnering with GPOs/GPLs to translate future-state processes into scalable solution designs.
- Skilled in vendor management and cross-team coordination.
- Clear, concise communicator in English.
- Willingness to travel across Ambu's footprint and collaborate across time zones.
- MedTech/life sciences background (GxP, ISO 13485, 21 CFR Part 11, CSV) is nice to have.
- Exposure to PLM, QMS, Infor M3 or equivalent ERP, plus iPaaS/data platforms, and modern security frameworks is nice to have.
Erfahrung
- 8+ years delivering technical workstreams on enterprise platforms (ERP, QMS, PLM or similar) in global settings.
- Hands-on experience with CI/CD, environment strategy, branching, automation testing, and code quality.
- Experience with Agile-at-scale combined with stage-gate governance is nice to have.
Unser Angebot
- Join a fast-growing, international company where your workstream leadership directly enables how we operate globally.
- We offer strong professional development and a competitive package of professional, social, and financial benefits.
Benefits
Work-Life-Integration
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
Ambu Innovation GmbH
Seit 1937 entwickeln wir bahnbrechende Ideen, um das Gesundheitswesen effizienter zu gestalten. Dies insbesondere in unseren vier Fachgebieten Visualisierung, Anästhesie, Patientenüberwachung und Diagnostik. Millionen von Patienten und medizinisches Fachpersonal weltweit vertrauen auf die Funktionalität und Leistungsfähigkeit unserer Produkte. Wir engagieren uns für die Verbesserung der Patientensicherheit und die Weiter- und Neuentwicklung von medizinischen Einweggeräten.
Description
- Gründungsjahr
- 1937
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Onsite
- Branche
- Gesundheitswesen, Soziales, Industrie, Produktion
QMS Technical Workstream Lead
- Ort
- Frankfurt am Main
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
- Nur Englisch
- Nur Englisch erforderlich
