Apprentice (m/f/d)
Guyancourt, FR, 78280
KARL STORZ France is looking for an Apprentice in Quality and Regulatory Department :
- Contribute to regulatory intelligence and monitoring (ISO standards, European regulations, FDA requirements, etc.).
- Participate in the maintenance and improvement of the Quality Management System (QMS) in accordance with ISO 13485.
- Contribute to the drafting, review, and updating of quality procedures and documentation.
- Participate in internal audits and support the preparation of external audits and inspections.Monitor quality performance indicators (KPIs) and contribute to continuous improvement initiatives.
- Participate in the management of customer complaints, medical device vigilance (materiovigilance), and product or batch recalls.
- Support Quality and Regulatory Affairs projects and other compliance-related activities as required.
Required profile is :
- Currently pursuing a Bachelor's or Master's degree in Quality Management, Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
- Strong interest in medical device regulations, quality systems, and compliance requirements.
- Basic knowledge of ISO 13485, EU Medical Device Regulation (MDR), or healthcare industry regulations is an advantage.
- Good analytical and problem-solving skills with attention to detail and accuracy.
- Strong written and verbal communication skills in French and English.
- Proficiency in Microsoft Office applications (Excel, Word, PowerPoint); knowledge of SharePoint or Power BI is a plus.
- Ability to work independently while collaborating effectively within a cross-functional and international team environment.
- Organized, proactive, and eager to learn in a dynamic Quality and Regulatory Affairs environment
Your Benefits
- Health insurance
- Vacation days (25 days /year)
- Additional days (between 10 or 13 days /year)
- Lunch vouchers
- Opportunity to work in an international and well-known company
- A supportive team and modern working-environment