QMS Technical Workstream Lead 1

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., * 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 (SoD), 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, * 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

• 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, * 8+ years delivering technical workstreams on enterprise platforms (ERP, QMS, PLM or similar) in global settings
• 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
• 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

• MedTech/life sciences background (GxP, ISO 13485, 21 CFR Part 11, CSV)
• Exposure to PLM, QMS, Infor M3 or equivalent ERP, plus iPaaS/data platforms, and modern security frameworks
• Experience with Agile-at-scale combined with stage-gate governance

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.

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.