Design Quality & Risk Manager

Role Overview

• Assure high quality of new product development in close collaboration with R&D
• Assure high quality of the product documentation
• Assure data accuracy and data integrity
• Support product registrations
• Coordinate Non-conformance process and the associated activities CAPA Management Process and Product Change Management and Documentation Controls
• Internal and Supplier Audits; support during external audits
• Collaboration with cross-functional teams
• Project Management Support to the quality lead on-site regarding other quality related processes
• Collaborate with Risk Management and Post Market Surveillance teams to ensure consistent documentation.
• Responsible for the Internal Audit Program
• Responsible for the Documentation Control, including control of external documents, primarily industry standards, regulations and guidance documents
• Monitor regulations and standards related to Design Control and implement necessary process changes

Requirements

• Minimum of 5 years professional experience in design and risk management of medical devices, specifically SaMD
• Experience in quality management or regulatory affairs of medical devices in a SW environment
• Bachelor or Master in engineering, computer science, life science or other related fields
• Profound knowledge of MDR, CFR FDA, MDSAP, ISO 13485, ISO 14971, IEC 62304
• Good technical understanding of software as a medical device and non-medical software products
• Fluency in English (written and spoken) – German is a plus.

Benefits

• Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.