Responsible for: ? Analyzing, collecting data, and providing accurate, documented information about the status of quality ? Verifying the correctness of quality related development results in compliance with the Quality Management Plan & authorize their release for medical devices ? Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA) ? Assessment of completeness of Design history file and Device master records ? Participate in reviews as per QMS, external and internal audits Experienced in: ? Product risk management & non-product software validation processes for medical devices ? Creation and maintenance of technical file/summary technical documentation (STED) ? Medical device development (including SW) and Software engineering best practices ? Agile methods / TIR45 Knowledge on: ? Implementing ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 within projects ? Compliance of requirements from MDR, QSR ? Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001) ? Non-regulated software like Apps for Apple / Android Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience Level: Experienced Professional Full / Part time: Full-time