Design Quality Professional, contract ends on 31 March 2029

Independently oversee the quality of product development activities and continuously improve, harmonize and develop risk management across global MedTech development sites. Work closely with quality, research and development, regulatory affairs, clinical development, production and post-market surveillance teams. The contract ends on 31 March 2029.

• Independently oversee design quality in product development, design changes, design transfers and lifecycle management
• Lead and facilitate product risk management activities under ISO 14971, including hazard analyses, FMEA and risk assessments for software, usability and cybersecurity
• Contribute risk management expertise and promote harmonization across sites and continuous improvement of processes, tools and governance structures
• Provide expert advice and support to cross-functional teams on risk-based decisions and effective risk management implementation
• Lead investigations, corrective and preventive actions (CAPAs) and complaint assessments, and manage product risk assessments using findings from post-market surveillance
• Support regulatory inspections and audits, including MDSAP, FDA QMSR and notified body audits, focusing on design controls and risk management
• Drive initiatives to develop risk management and improve inspection readiness

• Bachelor’s or master’s degree in engineering, life sciences or an equivalent qualification
• At least 6 years of relevant professional experience in medical device design quality, product development and risk management, or an equivalent combination of experience and expertise
• Strong expertise in ISO 14971 and extensive knowledge of ISO 13485, the EU Medical Device Regulation (MDR), FDA requirements and MDSAP
• Experience facilitating hazard analyses, FMEAs, benefit-risk assessments and post-market risk assessments
• Ability to influence and provide expert guidance to global, cross-functional teams and successfully drive change
• Experience supporting regulatory inspections and programs to address deficiencies
• Very good written and spoken German and English
• Experience leading organizational change initiatives, process harmonization programs or company-wide quality improvement projects is an advantage