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:
• Compliant to ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304, MDR, QSR within projects
• Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001)
• Non-regulated software like Apps for Apple / Android
        healthcare software development environment will be an added advantage

Excellent oral and written communication skills
Good to have certifications on ISO standards

Experience :  7-8 Years

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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