Design History File Trainee (m/f/d), Eysins

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

Your assignments

To support our Medical Device Development department and in collaboration with our Production Units we are searching for a minimum of 6 months a Design History File Trainee.

The trainee will support the remediation activities for existing and new products.

MAIN TASKS

• Support the structure and the overall content quality of multiple combination products Design History File (DHF)
• Identify eventual gaps and conduct appropriate remediation actions
• Coordinate the remediation activities and Perform DHF documents remediation accordingly in collaboration with accountable/responsible functions
• Define mandatory sources documents and ensure their availability and appropriate quality for filing a dossier. This can be testing raw data, tests results, third party reports, qualification documents, etc.…
• DHF documents update, maintenance and clean-up as needed
• Responsible for DHF transfer from SharePoint to Icologiq (new document management system)

Your profile

Education & Languages:

• Bachelor’s degree (or equivalent) in an applicable Product design, Scientific/engineering background
• Fluent in English, both oral and written; additional languages (German or French) are an asset

Specific competencies & skills:

• Good understanding of combination product / medical device, design control, documentation control, change control, quality system per ISO 13485, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan
• Good understanding of combination product / device design control
• Strong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholders
• Solid organizational skills including attention to detail and multi-tasking skills
• Problem solver mindset; good sense of autonomy and prioritization
• Effective verbal and written communication

Computer literacy:

• Word, Excel, PowerPoint, Outlook