Public summary
Join a leading medical technology company driving innovation in robotic-assisted surgery. The Quality Engineer will lead SAP-enabled quality process designs and improvements, collaborate cross-functionally, and ensure compliance with industry regulations in a manufacturing environment. This full-time onsite role requires experience in SAP modules, quality functions in regulated industries, and strong leadership skills. Opportunity to contribute to advancements in minimally invasive healthcare.
Location and work setup
- Location
- Freiburg im Breisgau
- Remote status
- On-site
- German requirement signal
- No German Required Detected
- Detected job language
- English
Responsibilities
Lead design, development, and implementation of SAP-enabled quality operations and engineering processes. Collaborate with cross-functional teams to define requirements and align SAP solutions with business objectives. Oversee testing and validation of SAP functionalities for system integrity and compliance. Drive continuous improvement initiatives and support sustainment of SAP performance. Serve as liaison among business units, IT, and vendors for SAP integration. Monitor industry trends to innovate quality processes. Ensure regulatory compliance specific to medical devices. Contribute to a Quality Center of Excellence and manage SAP solutions for quality functions adhering to industry standards.
Qualifications
Bachelor's degree with at least 5 years relevant experience or Master's degree with at least 3 years experience. Proven experience in SAP business process management (modules ME, MM, PP, QM) within manufacturing. Leadership experience managing teams and cross-functional projects. Experience in quality function leadership including process design, implementation, and compliance preferably in medical device industry. Strong communication, analytical, problem-solving, and decision-making skills. Familiarity with root cause investigation. Knowledge of ISO 13485 and EU MDR requirements. Understanding of Device History Records and Device Master Record relationships. Experience with Lean Manufacturing or Six Sigma methodologies. Willingness to travel domestically and internationally up to 25%. This is a fully onsite position.