Archiviertes Projekt - Quality Expert and QMS Coordinator (m/f/d)

For our client in Hesse, we are seeking a Quality Expert and QMS Coordinator starting in May (m/f/d) - 100% Remote.


 


Your tasks:


- 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


 


Your qualifications:


- 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


- 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.


- EN ISO 13485:2016 knowledge


- 21CFR Part 11 e-signature knowledge


- IT service provider/department process awareness


- GAMP 5 software validation knowledge


- 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