Contractor Quality Assurance (m/w/d)

Key Responsibilities

• Lead Design Quality Assurance activities to ensure compliance with ISO 13485, MDR/FDA requirements, and internal quality standards
• Support design control processes including risk management, design reviews, verification, and validation activities
• Act as Quality representative in cross-functional development projects
• Manage Supplier Quality Assurance activities, including supplier qualification, audits, and performance monitoring
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure seamless product development and supply chain quality
• Support continuous improvement initiatives within design and supplier quality systems

Qualifications

• Experience in Design Assurance and Supplier Quality within the MedTech industry
• Strong knowledge of ISO 13485, MDR and FDA
• Experience with risk management ISO 14971 and quality tools (FMEA, CAPA)
• Excellent communication and stakeholder management skills
• Fluent in English and German
• Able to be 4 days per week on-site