Location:
Bengaluru

Work mode:
Remote

Type:
full time

Experience:
10–15 years

Key Skills:
Quality Management Systems, ISO 13485, MDSAP, Medical Device Compliance, Audit & CAPA Management, Risk Management, Regulatory Compliance, Quality Process Improvement.

VisioGen is building the future of AI-powered healthcare by developing human-verified clinical communication solutions for ophthalmology practices. We combine cutting-edge Generative AI with clinical expertise to build scalable, production-ready applications that enhance patient engagement and improve healthcare delivery.

The Quality Management System Manager for ZEISS VisioGen is maintained with the required processes, templates, documentation, and controls. The role will help align VisioGen QMS practices with global healthcare quality requirements and ensure that software products are compliant with the defined QMS, ISO 13485, MDSAP, and applicable regulatory expectations. This role will report to the business leadership.

What you'll do
- Support development and maintenance of SOPs, Work Instructions, templates,



and working documents for product development and support processes.
- Coordinate with process owners to ensure standardization and control of QMS documentation.
- Track QMS updates as per quality standards and applicable regulatory requirements.
- Conduct trainings to help teams understand QMS processes, documentation practices, and compliance expectations.
- Guide project/product teams to follow QMS processes along with Quality Specialists and functional owners.
- Ensure regular management reporting as per QMS and quality standard requirements.
- Monitor project deliverables and ensure compliance with the defined QMS.
- Work closely with the QMR to support QMS compliance, continuous improvement, audit NCs, complaints, and CAPA actions.
- Support internal and external audit planning, audit readiness, and implementation of audit actions.
- Support project/product teams in root-cause analysis, defe

📌 Quality Management System Manager (Bengaluru)
🏢 RemoteEngine
📍 Bengaluru