Quality Engineer (m/w/d) Complaint Handling/Post Market Surveillance - zunächst auf 24 Monate befristet

In this role you investigate field complaints in the Post-Market Surveillance team, focusing on patient-specific products within the Craniomaxillofacial portfolio. You will combine technical and clinical analyses, collaborating with experts across functions to assess risk, manufacturing data, and potential trends. You drive data-driven investigations and cross-functional projects to improve product quality and performance. You act as the main contact for field performance of your product portfolio, contributing to compliance and continuous improvement. This position offers a chance to shape post-market outcomes in a regulated medical technology environment.

• Conduct structured investigations of reported field cases, including patient-specific products
• Analyze technical and clinical aspects and collaborate with subject-matter experts
• Discuss and evaluate cases based on investigations, risk assessments, and manufacturing data
• Collaborate with Quality, R&D, Manufacturing, Regulatory Affairs, and Clinical Affairs
• Independently analyze data to identify failure modes and trends
• Contribute to cross-functional projects aimed at sustainable product improvements
• Serve as the main point of contact for field performance of the assigned product portfolio

• Technical degree in mechanical engineering, medical engineering, materials science, or comparable qualification
• Initial practical experience in a quality function within a regulated industry
• Strong analytical and problem-solving skills with root cause analysis and trend identification
• Collaborative mindset and cross-functional communication
• Very good written and spoken German and English
• Preferred: experience with ISO 13485 and EU MDR (Regulation 2017/745)

• collaborative mindset
• strong communication skills
• cross-functional teamwork
• root cause analysis
• trend identification
• data analysis