Our key client who are a medium sized family business are currently expanding their QA/RA department and looking for someone to perform the following responsibilities with the following skills.
Key Responsibilities:
* Supplier Management: Evaluate, select, and continuously monitor suppliers to ensure they meet both internal and external standards.
* Supplier Audits: Plan and conduct both national and international supplier audits to uphold quality standards and regulatory compliance.
* Supplier Development: Develop and implement measures for supplier qualification and improvement in collaboration with purchasing and production teams.
* Performance Monitoring: Create and maintain supplier evaluations, and monitor their performance regularly.
* Quality Management Support: Assist in the preparation and execution of Quality Management (QM) audits to ensure adherence to regulatory requirements.
Candidate Profile:
* Educational Background: Degree in engineering, quality management, medical technology, or equivalent training (e.g., technician).
* Regulatory Affairs Expertise: Strong knowledge in Regulatory Affairs (RA) with practical experience in medical devices and relevant regulatory requirements (e.g., MDR, FDA).
* Quality Focus: High awareness of quality standards and practices.
* Technical Skills: Proficiency in MS Office and ERP systems, preferably Majesty.
* Language Proficiency: Excellent written and spoken skills in both German and English.
* Soft Skills: Strong teamwork and communication abilities, with a structured and reliable approach to work.