Design Quality Professional (m/f/d)

Ensure that design and development processes are appropriate, effective and compliant with applicable regulatory requirements and quality standards. Ensure that products are developed taking into account safety, effectiveness, quality, manufacturing, usability and compliance. Independent quality release of design and development documents, design changes and change control activities. the establishment, maintenance and management of risk management records in accordance with relevant standards; Management and moderation of risk management activities, including identification, assessment and control of risks related to ergonomics, application errors, software, cyber security and product-specific features. Ensure that appropriate documents for the design transfer are created and released, including DMR elements, specifications, test methods, test method validation and test plans. Support of project managers in quality planning, risk minimisation and compliance strategies. Head of Post-Market-Surveillance activities, including trend analysis and return of findings in design and risk management processes. Management of event handling and investigations into design-related complaints, non-conformities and CAPAs, including appropriate cause analyses and effective correction and prevention measures.

Knowledge of regulatory and quality requirements for medical devices, including MDSAP, FDA QSR (21 CFR 820), ISO 13485, ISO 14971, IEC 60601‐1, IEC 62304 and EU MDR. Detectional experience in Design Quality Assurance in the environment of medical devices, including product risk management and design and development of active medical devices. Practical experience in software development processes, product cybersecurity, design controls and usability engineering is advantageous. Excellent written and oral communication skills in German and English. Higher education or comparable technical training in engineering, life sciences or a related technical field. .