RemoteEngine
Website:
remoteengine.co
Job details:
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, defect prevention, and quality improvement activities.
- Maintain the Quality Management database and ensure compliance with documentation norms, naming conventions, version control, and approvals.
- Help define project/product metrics and support analysis and corrective actions where required.
- Participate in product/project cybersecurity assessment reviews, where applicable.
- Train and authorize team members on the internal Document Management System.
What we're looking for
- 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.
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