Technical System Owner – QMS (f/m/x)

   Aalen               ·              Full time

About the job

Your Role

• Monitor QMS processes and develop the process landscape to comply with MDSAP, ISO 13485, EU-MDR and other regulatory requirements
• Responsible for implementing the Quality Management Data Strategy & Roadmap to digitize the process landscape
• Responsible for the establishment of the data governance structure for reporting and analysis of business and management processes (including KPIs, etc.) and reporting on own process area
• In case of changes in the regulatory environment affecting the QMS, carry out GAP assessments
• Process owner for various processes in the quality management system e.g. document management, Learning & Training management, regulatory change management, CAPA Management, Audit management
• Cross team collaboration, i.e. building strategic alliances with technology team, process owner, product platforms to support digital transformation
• Contribution in activities like RFP (request for proposal) response, product solution briefings, drive POCs (proof of concept)
• Design workflow and process development with stakeholders within the content management system (CMS)
• Map functional development processes with a partner within the content management system so that predefined process specifications can be fulfilled (e.g. configure document templates)
• During the implementation phase, be responsible for the interface between developers, quality and product managers and the implementation partner, as well as for the product backlog (e.g. coordinate adjustments to the templates with the developers and the implementation partner)
• Take up new requirements for the CMS and take over the implementation of further processes and documents within the CMS as a key user (e.g. organize and lead meetings to coordinate with key users from another ZEISS group to align the risk management process)
• Create training materials and keep them up to date, as well as conduct user trainings (e.g. prepare a presentation and hold an online training on the creation of the SW specification document)

Your Profile

• Completed master’s degree in the field of data management, engineering or equivalent degree
• Several years of relevant professional experience in medical technology, e.g. MDSAP, ISO 13485, EU-MDR will be a benefit
• Several years of experience and affinity in the areas of application management or content management, as well experience in the use of electronic quality management system software
• Experience in software development as a project manager or product manager
• Experience in designing and optimizing processes
• Preferably experience with CMS software, such as Polarion
• Experience in project management and in the application of quality tools and methods
• Strong sense of quality, process and responsibility as well as high customer orientation
• A structured and goal-oriented way of working as well as strong conceptual skills
• A high degree of motivation, willingness to take on responsibility and enjoyment of familiarizing yourself with new topics
• Positive attitude in handling of deviations (failure culture)
• Agile mindset & open to new working methods
• Confident appearance, ability to work in a team and communication skills
• Very good interface management skills
• Confident handling of MS Office products
• Independent, structured and implementation-oriented way of working
• Very good written and spoken English as well as good German skills will be a benefit

Your ZEISS Recruiting Team: Megha Vishwakarma

Please click here to apply.