QA/RA Management

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.