Quality Management System Manager

RemoteEngine Technologies Private Limited; India; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

ZEISS VisioGen seeks a Quality Management System Manager to maintain and improve the QMS for regulated healthcare software products. You will ensure documentation, templates, and controls meet ISO 13485 and other global standards, while guiding cross-functional teams through quality processes.

The role requires extensive experience in healthcare software quality, audits, and risk management, with strong knowledge of MDR/FDA/ANVISA and Agile SDLC practices.

Qualifications

• 10-15 years of experience in product development, software quality, or regulated healthcare product environments.
• 6-7 years of experience in Quality Management for ISO 13485-based healthcare products or medical device/software environments.
• Experience with software development teams, including medical device software and/or SaMD.
• Strong knowledge of EU MDR, US FDA, ANVISA and other global regulatory expectations.
• Experience with ISO 13485:2016, MDSAP, and risk management per ISO 14971.
• Internal Auditor or Lead Auditor certification preferred.
• Knowledge of information security, data privacy, cybersecurity, and SDLC models including Agile.
• Knowledge of quality tools, audits, CAPA, root-cause analysis, and continuous improvement.
• Experience with distributed and cross-functional teams.

Responsibilities

• Maintain the QMS with required processes, templates, documentation, and controls.
• Align VisioGen QA practices with regulatory expectations.
• Collaborate with cross-functional teams to ensure regulatory compliance across products.
• Support audits, CAPA, and risk management activities.
• Contribute to continuous improvement of quality systems and practices.

Skills

Experience in software quality

Regulated healthcare product

Auditor knowledge or Lead Auditor

Information security & data privacy

Software development lifecycle (Agile)

Quality tools & CAPA

Cross-functional collaboration

Education

Bachelor's or Master's in Science/Engineering/Healthcare/Tech

Job description

ZEISS 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 Visio Bachelor's or Master's degree in Science, Engineering, Healthcare Technology, Life Sciences, Computer Science, or related discipline.

• 10-15 years of experience in product development, software quality, or regulated healthcare product environments.
• 6-7 years of experience in Quality Management for ISO 13485-based healthcare products or medical device/software environments.
• Experience working with software development teams, including medical device software and/or SaMD.
• Strong knowledge of regulations applicable to medical device and healthcare software manufacturers, including EU MDR, US FDA, ANVISA, and other global regulatory expectations.
• Experience with ISO 13485:2016, MDSAP, and risk management for medical devices based on ISO 14971.
• Internal Auditor or Lead Auditor certification for ISO 13485:2016 is preferred.
• Knowledge of information security, data privacy, cybersecurity, and software development lifecycle models, including Agile.
• Knowledge of quality tools, statistical methods, audits, CAPA, root-cause analysis, and continuous improvement practices.
• Experience working with distributed and cross-functional teams.