Quality Assurance Manager

Your main tasks Coordinate quality assurance activities in design and development projects Provide quality guidance on project and product compliance, design controls and design changes in collaboration with Development, Software, Risk Management, Regulatory Affairs and Product Care Participate in risk assessments and support regulatory submissions by ensuring relevant quality requirements and documentation are addressed Support the investigation and follow-up of product-related non-conformities, deviations and potential design weaknesses Contribute to complaint handling and Quality Progress Reviews, using market feedback to identify and coordinate appropriate quality actions Review relevant quality documentation and support compliance with applicable internal, customer, industry and regulatory requirements Coordinate stakeholder input, maintain oversight of open quality topics and prioritise requests across projects and products Provide professional quality leadership within projects, clarify expectations and coordinate the contribution of relevant stakeholders Support quality improvements and contribute to internal, customer and authority audits within your area of responsibility Your profile University degree in a scientific or comparable discipline, or an equivalent combination of education and relevant experience Several years of practical Quality Assurance experience in a regulated industry, such as medical technology, pharmaceuticals or biopharmaceuticals Strong knowledge of quality assurance methods and relevant standards and regulations, such as ISO 13485, EU MDR, 21 CFR Part 820 and GMP Experience with design control, design changes or quality assurance in product development Experience supporting regulatory submissions is an advantage Strong stakeholder management skills and confidence coordinating cross-functional project teams Excellent communication skills, with the ability to provide clear quality guidance and manage differing priorities Strong organisational skills, attention to detail and a solution-oriented approach Fluent in English; German is an advantage