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Project Quality Engineer

Job Description

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

Job Type: Full-time

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