Berlin, Germany
18 hours ago
Head of Quality Operations (site Berlin) (f/m/x)

Seeing beyond - future of medical technology

For more than 100 years, ZEISS medical technology has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve people's vision at every stage of their lives. In microsurgery, our solutions enable targeted interventions on diseased tissue so that small and sensitive organs continue to function optimally. Medical technology from ZEISS supports medical professionals in improving the lives of patients worldwide. The fact that our actions have a direct impact on people's well-being is what drives us every day.

Your role

In this position, your key responsibility will be the disciplinary and functional leadership, the continuous enhancement, as well as the oversight of the Quality Operations department at the Berlin site.

Leadership and People Management: Be a role model by fostering, coaching, and trusting employees in accordance with the ZEISS Leadership Principles. Cultivate and promote ZEISS culture and values while driving performance through clear and ambitious goal setting.

Implementation and Monitoring of the Quality Management System: Oversee the local implementation and application of quality-related processes and process KPIs to ensure the effectiveness of the quality management system. Set and evaluate Quality Objectives based on the Quality Policy's requirements, and routinely define and carry out the internal audit program. Conduct the Quality Management Review and participate and report regularly in site Management Meetings and follow up on actions as necessary

Continuous Improvement of Product Quality: Surveillance of change control projects and Corrective and Preventive Actions (CAPA) in collaboration with relevant interfaces, including Complaint Management and Supplier Quality Management, as well as reporting to the appropriate steering committees. Create and Maintain product risk Management files.

Quality Management Production: Manage and preserve verification and validation frameworks to make certain that product-related quality aims are reliably met.

R&D and Product Innovation: Decide on the initial product launches and verify safety and effectiveness as required.

Your Profile

University education as Bachelor/Master of Science or Engineering/related degree programs

Profound experience in the development and improvement of quality management and quality improvement measures in the field of medical technology

Practice as an internal auditor required

In-depth knowledge of relevant international standards and regulations in medical technology such as ISO 13485, 21CFR820, the european Medical Device Regulation

Relevant experience in the application of methods and tools in quality management (such as SIX SIGMA, FMEA, 8D, CAPA, etc)

Fluent English and German skills in spoken and written communication

Your ZEISS Recruiting Team:

Nicole Kraft-Henzelmann
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