PURPOSE AND SCOPE:

The Quality Expert and QMS Coordinator supports the senior Quality Specialists in ensuring the effective implementation and maintenance of the quality management system (QMS) within the IT department. This role focuses on providing operational support across various quality assurance activities to uphold standards and compliance.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Assist in quality assurance procedures, including documentation management and adherence to established processes.
• Provision of requirements for the design and implementation of IT processes and controls within the QMS framework.
• Participate in the design and documentation of IT processes and controls, ensuring alignment with quality standards and objectives.
• Generate and compile reports related to quality metrics, process performance, and compliance indicators.
• Execute established processes and controls, following defined procedures and guidelines.
• Support training initiatives by assisting in the development of training materials and documentation.
• Stay informed about certification requirements relevant to the services provided by the IT department and notify relevant stakeholders accordingly.
• Identify roles and responsibilities within the QMS framework, assisting in defining clear accountability and ownership.
• Assist in system inventory management, including tracking assets and maintaining accurate records.
• Collaborate with senior Quality Specialists to address issues, implement improvements, and drive continuous enhancement of the QMS.
• Participate in QMS audits and inspections, providing support and documentation as needed.
• Contribute to the documentation of processes, procedures, and best practices within the QMS.
• Assist in the development and maintenance of documentation repositories and knowledge bases.
• 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)
• Understanding the method for the management of IT departments providing GxP system support/management
• Responsible for compliance in alignment with the defined QMS processes
• Responsible for the continuous improvement of the QMS framework

EDUCATION:

• 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

EXPERIENCE AND REQUIRED SKILLS:        

• 2-3 years of experience in a quality assurance or operational support role within the IT industry.
• Familiarity with quality management principles and practices.
• Proficiency in documentation management and process execution.
• Knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
• Your work ethic is characterized by a strong self-motivated, systematic and analytical approach
• Pay close attention to details
• Strong communication and project management skills as well as a strong service and result oriented working style
• Good general Project & Program Management skills
• Must be a self-starter with strong creation to execution skills.
• The ability to troubleshoot and resolve system-related issues effectively.
• An enterprise wide mind-set – building productive working relationships
• Cultural sensitivity and understanding.  Able to effectively deal with international/cultural differences.
• Excellent oral and written communication

• Please list the qualities that are of special significance for the successful performance of tasks if they have not been outlined sufficiently in a attached competence profile.

• Your work ethic is characterized by a strong self-motivated, systematic and analytical approach
• Pay close attention to details
• Strong communication and project management skills as well as a strong service and result oriented working style
• Good general Project & Program Management skills
• Must be a self-starter with strong creation to execution skills.
• The ability to troubleshoot and resolve system-related issues effectively.
• An enterprise wide mind-set – building productive working relationships
• Cultural sensitivity and understanding.  Able to effectively deal with international/cultural differences.
• Excellent oral and written communication
• Ability to adapt to business strategy or changes in priorities
• EN ISO 13485:2016 knowledge
• 21CFR Part 11 e-signature knowledge
• IT service provider/department process awareness
• GAMP 5 software validation knowledge
• high language proficiency in English
• German a benefit
• Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc
• Knowledge of computer software validation and computer software assurance principals
• Knowledge and understanding of business systems, Windows Office, Teams, Projectplace, Visio etc
• Basic familiarity with the production of medical devices or pharma products
• Understanding of IT service management principles and frameworks, such as ITIL.
• Knowledge of quality management standards and frameworks, including ISO 9001.
• Willingness to be on site as needed
• Willingness to travel within Europe and in the US as needed to support projects.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity 

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.