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Fresenius Medical Care LinkedIn

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Expert in software systems management, infrastructure, interfaces and server management. This role will take the ownership of the Trackwise instance within Fresenius Medical Care globally. In this role, the individual will be a key liaison for the business in regards to the technical capability of the solution, the interfaces, the impact of changes and upgrades required to ensure continuous availability of the validated global tool. This role will also be a key interface to other technical groups with DTI, ensuring the digital connectivity of this solution and support in the design and build of global quality management and regulatory systems (QMRS).

Tasks performed regularly:

  • Expertise for guiding the business and the QMRS team on project/change requests to ensure ongoing integration and improved integration of QMS processes
  • Regular technical administration and maintenance activities on behalf of the collection of QMRS systems and their interfaces for ongoing operations
  • Expert for Trackwise and the data model, system build for ongoing management and changes - Designing and maintaining the technical architecture of the QTRAK system.
  • Expertise for support team to go to when 3rd level support questions require guidance
  • Managing system availability, back ups and coordination with any data center teams, infrastructure teams or external vendors providing services of this nature.
  • Manage Microsoft Windows server systems and technical architecture.
  • Guiding DTI teams and business in relation to new IT project/changes to software’s on topics of interfaces, infrastructure, data migration
  • Lead expert for any system upgrade projects
  • Recommend new systems/technologies, given the business needs
  • Manage data migration plans from any existing technologies
  • Expert liaison for interface management on daily basis to ensure connectivity of systems
  • Ensure business continuity for all systems within the responsibility of QMRS
  • Issue investigation and resolution/debug complaints with the system should items occur
  • Ensure systems are meeting regulatory requirements – include GDPR
  • Ensure cybersecurity controls and concerns are factored into any IT projects
  • Support with system testing during validation of software toolings as needed to support the implementation team.
  • Train new administration team members when heightened access rights are needed to servers/background of systems
  • Propose system improvement ideas whilst maintaining the broader view of the software ecosystem and interconnectivities
  • Support with data gathering for business case build for new project and budget applications
  • Support with approvals/invoicing as needed
  • Lead a team of software engineers as team builds or projects are approved
  • Ensure budget management and on budget delivery of projects
  • Ensure business continuity of systems for highly regulated environment
  • Helping set QMRS ecosystem strategy in line with Head of QMRS
  • Delegate for Head of QMRS on technical documents/approvals
  • Oversight of developers to ensure business needs are met and suit the global roadmap are architecture of projects

Qualifications:

  • Working knowledge of configuration and design functionality within Trackwise system
  • You demonstrate good handling of IT office tools (Email, MS Word, Excel and PowerPoint), the database tool SQL
  • Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)
  • Proven track record in leading complex projects and solving system problems within a cross functional team
  • Vocational training, university degree, PhD, MBA, specialized further education etc.
  • Supporting the management of IT-projects and documentation of requirements based on best practices. You have a graduate degree in economics or engineering (B.Sc./ MBA) or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role
  • Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
  • Professional experience in the administration and development of quality as well as documentation management software systems (TrackWise, MasterControl, Pilgrim or similar)
  • Professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred
  • Relevant experience with Quality system IT Platforms (e.g. Trackwise, Tableux, Compliancewire, Agile/Windchill, etc)
  • Knowledge of the Product Life Cycle software system, such as Windchill
  • Knowledge and understanding of key enterprise systems used in a medical device such ERP/SAP, MES/Werum, LIMS/LabWare, CRM/Salesforce and End-to-end Processes in the medical device companies.


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