Quality Manager

Carl Zeiss CMP GmbH belongs to the global ZEISS manufacturing network and provides services related to the development and production of optomechanical and optoelectronic modules and components. The core competence lies in the production of highly corrected spherical optical systems, which are used in particular in high-performance microscope objectives.

• Actively shape quality management: You develop quality concepts and standards for new developments, changes and existing manufacturing processes and coordinate them with relevant specialist departments and across sites within the ZEISS network.
• Sustainably solve quality problems: You analyze internal quality deviations and field failures at the customer, conduct structured root cause analyses and develop effective measures for error prevention and sustainable process stabilization.
• Control quality processes: You initiate and monitor quality measures, evaluate their effectiveness and initiate corrective measures where necessary. In doing so, you define suitable test methods and test strategies and make quality decisions even in borderline and special cases.
• Implement regulatory requirements: You evaluate new normative and regulatory requirements and transfer them into our processes and management system. You work closely with internal interfaces, other ZEISS companies, customers and certification bodies.
• Further develop QM system: You actively participate in the continuous further development of our quality management system, create and maintain quality-relevant documentation, work instructions, test regulations and quality standards.
• Professionally accompany audits: You plan, conduct and document internal and external audits and support the implementation and follow-up of resulting measures.
• Secure qualification, validation and changes: You support the planning, execution and documentation of qualifications and validations of equipment, processes and devices as well as the evaluation and implementation of changes within the scope of change management.
• Apply quality methods: You use established methods such as 8D, 5-Why, Ishikawa, FMEA, CAPA, risk analyses or SPC and continuously develop existing procedures, methods, test strategies and systems.
• Work interdisciplinary: You take responsibility in quality-related projects and sub-projects and work closely with development, production, industrial engineering, purchasing, suppliers and other relevant interfaces.

• You have a completed technical or scientific degree, for example in engineering, mechanical engineering, medical technology, pharmacy or chemistry. Alternatively, you have a completed technical vocational training with relevant further education and several years of relevant professional experience.
• You have sound professional experience in quality management, ideally in a regulated environment or in medical technology.
• You have sound knowledge of DIN EN ISO 13485 as well as ideally further regulatory and normative requirements such as ISO 14971, MDSAP, IVDR, GMP and European medical device law.
• You have experience in using quality methods and tools such as 8D, FMEA, CAPA, risk analyses, SPC and structured root cause analyses.
• Knowledge in the area of qualification and validation of equipment and processes as well as in change management is an advantage.
• Ideally, you have training or practical experience as an internal auditor.
• You are characterized by a structured, analytical and independent way of working as well as a pronounced quality and responsibility awareness.
• You have the ability to communicate complex technical and regulatory issues appropriately to the target audience and convince with strong communication and interface skills.
• You enjoy working in an interdisciplinary and international environment and have very good German and English skills. Further language skills, for example Chinese, are an advantage.