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