Siemens

Project Quality Engineer - with AI Process Specialist

Siemens  •  Bengaluru, IN (Onsite)  •  1 day ago
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Job Description


Job ID

517416

Posted since

10-Aug-2026

Organization

Siemens Healthineers

Field of work

Quality Management

Company

Siemens Healthcare Private Limited

Experience level

Experienced Professional

Job type

Full-time

Work mode

Office/Site only

Employment type

Permanent

Location(s)

  • Bangalore - Karnataka - India

SHS AT QT (Advanced Therapies Quality & Regulatory Team) is a global organization focused on ensuring product quality, regulatory compliance, and patient safety across the product lifecycle. It supports innovation by integrating Quality Engineering, Risk Management, Reliability Engineering, and regulatory expertise into product development. The team drives digitalization, AI adoption, and continuous process improvement to enhance efficiency and compliance. SHS AT QT aims to deliver high-quality healthcare solutions faster, enabling better outcomes for patients, customers, and healthcare providers worldwide.
 

Responsibility 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
  • Provide process expertise and guidance for AI-enabled products throughout the development and maintenance lifecycle. 
  • Assess and improve AI governance, risk management, and lifecycle management processes to ensure effectiveness and compliance. 
  • Review AI-related documentation and evidence to support product releases, regulatory submissions, audits, and technical file updates. 
  • Facilitate alignment of AI development activities with applicable quality, regulatory, and organizational requirements.
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
  • Experienced in end-to-end AI lifecycle processes, including data management, model development, validation, deployment, monitoring, and change management. 
  • Supports teams in implementing AI governance practices, documentation requirements, and lifecycle controls for AI-enabled products. 
  • Reviews AI-related assessments, identified risks, performance issues, and compliance gaps, and supports appropriate corrective actions. 
  • Supports maintenance of AI-related documentation and records to ensure audit readiness and regulatory compliance.
Knowledge
  • Implementing ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 within projects
  • Compliance of requirements from MDR, QSR
  • Non-regulated software like Apps for Apple / Android
  • Strong knowledge of AI governance frameworks, AI lifecycle management processes, and AI risk management principles. 
  • Knowledge of regulatory expectations for AI-enabled healthcare products across global markets, including FDA, EU, and other international regulators. 
  • Familiarity with AI-related standards and guidance such as ISO/IEC 42001, ISO/IEC 23894, ISO 14971, GMLP (Good Machine Learning Practice), and applicable AI regulatory frameworks.
  • Understanding of how AI requirements integrate with medical device quality systems, software lifecycle processes, and regulatory documentation.

Siemens

About Siemens

Siemens AG (Berlin and Munich) is a leading technology company focused on industry, infrastructure, mobility, and healthcare. The company’s purpose is to create technology to transform the everyday, for everyone. By combining the real and the digital worlds, Siemens empowers customers to accelerate their digital and sustainability transformations, making factories more efficient, cities more livable, and transportation more sustainable. A leader in industrial AI, Siemens leverages its deep domain know-how to apply AI – including generative AI – to real-world applications, making AI accessible and impactful for customers across diverse industries. Siemens also owns a majority stake in the publicly listed company Siemens Healthineers, a leading global medical technology provider pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. In fiscal 2025, which ended on September 30, 2025, the Siemens Group generated revenue of €78.9 billion and net income of €10.4 billion. As of September 30, 2025, the company employed around 318,000 people worldwide on the basis of continuing operations.

Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Munich, DE
Year Founded
Unknown
Website
siemens.com
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