Quality Management System Analyst

at  Fresenius Medical Care

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

OUR REQUIREMENTS:

• Bachelor’s degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role
• 1+ years of professional experience working with or owning computer software validation/system coordination
• Strong EN ISO 13485:2016 knowledge
• 21CFR Part 11 e-signature knowledge
• IT service provider/department process awareness
• GAMP 5 software validation knowledge
• Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
• Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc
• Experience of working in a company manufacturing under GxP environment
• Strong communication and project management skills as well as a strong service and result oriented working style
• Additionally, minimum of 3 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred
• Fluency in the English language in the business environment (at least B2)
• German language knowledge (different than Polish and English) will be an asset.
• Knowledge of computer software validation and computer software assurance principals
• Willingness to travel within Europe and in the US as needed to support projects.

• Act as deputy for the department management representative
• Perform support during any required audits, and participate in audit preparation or hosting
• Implement any assessed and required QMS procedures from CE for impact to DTI
• Write and own department specific documents (as necessary)
• Ensure compliance and alignment to applicable regulations within DTI as a whole
• Provide support for the alignment of any IT process guidances with the QMS mandatory requirements
• Ensure governance of the implementation of any applicable QMS processes within DTI
• Support with the oversight of monitoring metrics and reporting to CE for the department
• Ensure document control, management and archiving is in place for all DTI documents for GxP systems or processes
• Point of contact/SME for any NC or CAPA owned by DTI
• Ensure action completion for any tasks out of NC or CAPA required by DTI
• Oversee the update and storage of department organizational charts
• Ensure the timely deployment of training relevant for departments within DTI
• Generate the internal metrics for DTI service, and internal KPIs
• Report to Senior QMS Expert the progress of the QMS implementation within DTI
• Identify any risks or issues relating to adoption of the processes
• Provide guidance/support to other departments implementing a process
• Coordinate liaisons between CE and DTI regarding QMS implementation/feedback
• Point of contact for DTI employees in understanding if their software is GxP relevant
• Ensure IT adopted QMS and IT processes are meeting regulatory requirements and cybersecurity controls
• Follows all policies, guidelines, and SOPs as required