Consultant Quality Management (m/f/d)

Seeing beyond - future of medical technology For more than 100 years, the medical technology of ZEISS has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve the vision of people at any time of life. In microsurgery, our solutions enable targeted interventions on the diseased tissue, so that small and sensitive organs continue to function optimally. ZEISS's medical technology supports medical professionals to improve the lives of patients worldwide. The fact that we have a direct influence on the well-being of our people is our daily drive.

Your role Qualification & validation You are responsible for the planning, implementation and documentation of qualifications and validation of systems, processes and devices.

You create and maintain validation plans, reports and risk analyses and provide comprehensive technical documentation.

You perform process validations and change control evaluations and ensure that all relevant standards and guidelines are complied with.

Quality management & documentation You develop and optimise work instructions and test regulations and contribute to the further development of our quality management system.

You process deviations and support CAPA measures as well as the documentation of change requests.

You are actively involved in internal and external audits and contribute to continuous improvement.

Analysis and Process Optimization You carry out cause analyses (5-Why, 8D, Ishikawa) and implement measures for process stabilization and avoidance.

You work with interdisciplinary projects for quality and process improvement and contribute to the optimization of our processes.

Your profile You have completed their studies in a technical or scientific field (e.g. engineering, mechanical engineering, medical technology, pharmaceuticals, chemistry).

You have professional experience in quality management, ideally focusing on qualification and validation.

You are familiar with regulatory requirements (e.g. ISO 9001, ISO 13485, GMP, IATF 16949) and have knowledge of Q methods such as FMEA, CAPA and risk analyses.

You work structured, analytical and independent and possess excellent communication skills.

You speak very well German and English and have a high quality awareness. (nice to have: ideally Chinese)

As a speaker:in quality management, you are the key to the safety and reliability of our systems and processes as well as to the further development of our quality management system. Their role is not only varied and responsible, but also of great importance, as your work directly influences the quality of our end products. Become part of our team and actively shape the future of quality assurance. .