QMS Technical Workstream Lead 1

QMS Technical Workstream Lead 1

Frankfurt am Main Vollzeit 80000 - 100000 € / Jahr (geschätzt) Homeoffice (teilweise)
Ambu A/S

Auf einen Blick

  • Aufgaben: Leite die technische Umsetzung für das QMS und arbeite eng mit globalen Prozessführern zusammen.
  • Unternehmen: Wachsendes internationales Unternehmen im MedTech-Bereich mit Fokus auf innovative Lösungen.
  • Vorteile: Attraktives Gehalt, berufliche Entwicklung und ein dynamisches Arbeitsumfeld.
  • Weitere Informationen: Reisebereitschaft und Zusammenarbeit über Zeitzonen hinweg sind erforderlich.
  • Warum dieser Job: Gestalte die Zukunft des Qualitätsmanagements und mache einen echten Unterschied in der Branche.
  • Qualifikationen: Mindestens 8 Jahre Erfahrung in technischen Workstreams und starke Führungsfähigkeiten.

Das prognostizierte Gehalt liegt zwischen 80000 - 100000 € pro Jahr.

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.

Ambu is transforming our core enterprise platforms (e. g., ERP, QMS, PLM), and each workstream needs a dedicated technical leader to ensure high-quality, compliant delivery that enables standardized, high-performing global processes.

This job ad regards the QMS Workstream Lead Position

The role

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.

  • QMS technical workstream lead
  • Experience in implementing QMS systems
  • Good understanding of workflows normally used within QA across the value chain
  • Good understanding of the system landscape needed to support QA via the QMS
  • Good understanding of the complex data and data structures used in product development

Key responsibilities

  • Technical governance within your workstream
  • 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
  • Design, build, environments, and release engineering
  • 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
  • Data migration and cutover
  • Plan, prepare and execute migration tooling, trial loads, reconciliations/ validation, and cutover steps for your workstream objects
  • Security, privacy, and compliance
  • Ensure cybersecurity, privacy, Segregation of Duties (So D), and validation/CSV compliance in collaboration with QA/Validation Lead
  • Delivery orchestration and hypercare
  • 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
  • Program collaboration
  • 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

Your profile

  • 8+ years delivering technical workstreams on enterprise platforms (ERP, QMS, PLM or similar) in global settings
  • Proven leadership of architecture, integrations (API/i Paa S), data migration, and release management within a defined scope
  • Strong command of non-functionals: performance, reliability, security, privacy, So D, and validation/CSV
  • Hands-on experience with CI/CD, environment strategy, branching, automation testing, and code quality
  • 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
  • Nice to have
  • Med Tech/life sciences background (Gx P, ISO 13485, 21 CFR Part 11, CSV)
  • Exposure to PLM, QMS, Infor M3 or equivalent ERP, plus i Paa S/data platforms, and modern security frameworks
  • Experience with Agile-at-scale combined with stage-gate governance
  • Key stakeholders for your workstream
  • Global Process Owner and Global Process Leads
  • PMO
  • External implementation partners and software vendors

Key responsibilities following the transformation

  • 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
  • Ambu – where your technical leadership matters

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.

  • Note
  • #J-18808-Ljbffr

QMS Technical Workstream Lead 1 Arbeitgeber: Ambu A/S

Ambu ist ein globaler Marktführer in der medizinischen Geräteinnovation und bietet eine dynamische, internationale Arbeitsumgebung, die Vielfalt und Zusammenarbeit schätzt. Als Senior QM R&D Engineer haben Sie die Möglichkeit, an bedeutenden Projekten zu arbeiten, die die Patientenversorgung verbessern, während Sie von umfangreichen Weiterbildungsangeboten und einem unterstützenden Team profitieren. Bei Ambu fördern wir eine Kultur der Innovation und des kontinuierlichen Wachstums, was uns zu einem hervorragenden Arbeitgeber macht.

Ambu A/S

Kontaktdaten:

Ambu A/S Recruiting-Team

Wir glauben, dass du diese Fähigkeiten brauchst, um QMS Technical Workstream Lead 1 mit Bravour zu bestehen

Technische Governance
QMS-Systemimplementierung
Workflow-Verständnis im Qualitätsmanagement
Systemlandschaft für QA
Datenmigration und -validierung
Architektur und Integrationen (API/iPaaS)
CI/CD und Automatisierungstests