Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your qualified and personal growth, all while valuing your unique contributions.

Establishes the defined Quality Management system tailored/aligned to the project-specific requirements to ensure process and product quality in service/solution project to achieve customer satisfaction and business success. Acts as a member of the project core team with special focus on failure prevention. Advocates to a higher quality aspiration.The Quality System Manager plays a critical role in advancing quality systems, regulatory compliance, and business performance for software-based medical device development. This position is responsible for driving quality strategy execution in alignment with site quality management and business leadership priorities,



while ensuring compliance with applicable international regulations, standards, and global regulatory expectations.
Key responsibilities include:
- Lead the establishment, implementation, and maintenance of quality system requirements and business objectives for medical device software and Software as a Medical Device (SaMD) development projects in alignment with applicable procedures, regulations, and international standards.
- Develop, mentor, and lead a team of quality professionals to support compliance, business growth, product quality, and customer experience.
- Drive continuous improvement initiatives and organizational change efforts that enhance business agility, quality performance, and operational effectiveness, including through the CAPA system.
- Partner effectively across functions to identify and address quality risks, business opportunities, and process improvement priorities.
- Implement process and compliance improvemen

📌 Quality System Manager (Pune)
🏢 Siemens Healthineers
📍 Pune