(Senior) CAPA Specialist (m/f/d) Medical Devices

As a (Senior) CAPA Specialist (m/f/d) Medical Devices, you will play a critical role in ensuring the effectiveness and compliance of our NC (Non-Conformance) and CAPA (Corrective and Preventive Action) processes. You will collaborate with cross-functional teams to drive issue resolution, enhance problem-solving methodologies, and maintain compliance with global quality and regulatory requirements.

This is initially 24 months fixed-term position.

What You Will Do

• Review and approve NCs and CAPAs, ensuring completeness, accuracy, and timely resolution.
• Guide and support teams through all stages of the NC/CAPA process, facilitating problem-solving techniques such as 5 Whys, fishbone diagrams, and process mapping.
• Act as an eCAPA system super-user and provide training to ensure adherence to CAPA procedures.
• Monitor site NC/CAPA KPIs, generate reports, and support quality and business review forums.
• Lead NC/CAPA Review Board meetings, ensuring alignment with global requirements and continuous improvement.
• Support internal and external audits related to NC/CAPA processes.
• Drive collaboration and standardization across global teams to enhance CAPA effectiveness.
• Identify process improvements to enhance efficiency and compliance.
  
  

• BS in Engineering, Science, or related degree; MS is preferred. OR you have a Technician/Meister degree with minimum 4 years of experience in a quality discipline.
• 0-5 years of experience in a regulated environment (Medical Devices, Pharmaceuticals, or similar). The role level (Specialist or Senior Specialist) will be determined based on experience.
• Strong communication skills and the ability to manage multiple priorities effectively.
• Your English and German language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.
  
  

• Experience with CAPA, NC management, or quality systems in a regulated industry.
• Understanding of ISO 13485, MDSAP, and FDA 21 CFR Part 820 quality regulations.
• Familiarity with problem-solving methodologies and continuous improvement initiatives.
• Strong analytical skills and attention to detail.
  
  

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 3-4 days a week on site in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title.