Apprentice (m/f/d)

KARL STORZ; Guyancourt; Sur place; EUR 12 000 - 18 000; Plein temps

Avantages offerts par ce poste

Health insurance

Vacation days 25 days/year

Additional days 10–13 days/year

Lunch vouchers

Work in an international company

Supportive team and modern environment

Résumé du poste

KARL STORZ France is seeking an Apprentice in the Quality and Regulatory Department to support regulatory intelligence, maintain the QMS in line with ISO 13485, and help update quality procedures. You will participate in internal audits, support external inspections, monitor KPIs, and assist with complaints, vigilance, and product recalls.

Ideal candidates are pursuing a Bachelor's or Master's in Quality Management or Regulatory Affairs, have interest in MDR/regulations, and can communicate

Qualifications

• 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.
• Good analytical and problem-solving skills with attention to detail and accuracy.
• Proficiency in written and spoken French and English.

Responsabilités

• Contribute to regulatory intelligence and monitoring (ISO standards, European regulations, FDA requirements, etc.).
• Participate in the maintenance and improvement of the QMS in accordance with ISO 13485.
• Contribute to drafting, review, and updating quality procedures and documentation.
• Participate in internal audits and support external audits and inspections; monitor KPIs and drive continuous improvement.
• Assist in managing customer complaints, medical device vigilance, and product recalls.
• Support Quality and Regulatory Affairs projects and other compliance activities.

Connaissances

Regulatory intelligence

QMS ISO 13485

Regulatory affairs

Attention to detail

Bilingual FR/EN

Cross-functional collaboration

Formation

Bachelor's or Master's in Quality Management or Regulatory Affairs

Outils

MS Office

SharePoint

Power BI

Description du poste

KARL STORZ France is looking for an Apprentice in Quality and Regulatory Department :

Responsibilities

• 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