Job
- Level
- Lead
- Job Field
- Application, Project
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Frankfurt
- Working Model
- Onsite
Job Summary
In this role, you lead the technical aspects of the QMS workstream, taking ownership of architecture, data migration, and security standards while closely collaborating with global process leaders.
Your role in the 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.
- Führen Sie die technische Governance für den Arbeitsbereich.
- 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.
- Leads the 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.
- Leads 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.
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Our expectations of you
Qualifications
- 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.
Experience
- 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.
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What we offer
- 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.
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Benefits
Work-Life-Integration
Topics that you deal with on the job
Job Locations
This is your employer
Ambu Innovation GmbH
Our company has been developing groundbreaking ideas since 1937, paving the way for more efficient solutions in healthcare. We specialize in four areas: visualization, anesthesia, patient monitoring, and diagnostics. Millions of patients and medical professionals around the world rely on the functionality and performance of our products. We are committed to improving patient safety and developing new medical devices.
Description
- Founding year
- 1937
- Company Type
- Established Company
- Working Model
- Onsite
- Industry
- Healthcare, Social Sector, Industry, Production
QMS Technical Workstream Lead
- Location
- Frankfurt
- Working Model
- Onsite
- Diversity
- Open for all genders
- English Only
- English only required
