QA Engineer

Responsibilities Ensure compliance requirements according to Medical Device Regulations ISO 13485 and the company quality manual. Guarantee that suppliers deliver quality parts, materials, and services. Review and approve final product quality acceptance. Administrate and monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier‑related problems as they occur. Generate analysis of non‑conforming parts returns. Support the supplier evaluation to assess overall performance and provide feedback in assessment of their operation. Support and evaluate manufacturing issues with root cause analysis and corrective actions implementation. Ensure in close collaboration with manufacturing that all production processes are compliant. Qualify suppliers according to company standards. Perform supplier audits. Qualifications Completed technical education with further training in the quality area. Experience in quality assurance and working with regulations. Experience with supplier auditing preferred. Independent, communicative, and capable of working autonomously. Fluency in German, written and verbal, is mandatory; proficiency in English is preferred. Minimum 3 days per week onsite. We welcome applications from individuals with disabilities. #J-18808-Ljbffr