As part of our RA / QA team you will have the unique opportunity to use your knowledge in regulatory and quality management systems and your passion for technology to bring to market cutting-edge AI-driven medical devices that positively impact patient lives at scale.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) and quality-related policies and procedures in accordance with ISO13485, IEC62304, FDA 21CFR Part 820 and other relevant medical device standards and regulations
- Champion Annalise-AI’s Quality Management System throughout the business to help ensure positive engagement and regulatory compliance
- Support the monitoring and improvement of quality objectives and KPIs throughout the business
- Manage key QMS processes, including but not limited to:
- NCR/CAPA
- Post-Market Surveillance and Complaint Handling
- Support key QMS processes, including but not limited to:
- Document Control
- Change Control
- Supplier Management
- Assist with internal / external audits and management reviews, where required
- Execute quality improvement projects
- Train internal stakeholders on quality principles and processes
- Comply with all company policies, procedures and guidelines, including following all Quality Assurance and Information Security requirements. This encompasses:
- Reading, understanding and complying with the policies and procedures that are relevant to your role within the Quality,Information and Security Management Systems
- Where applicable, report any product/ process issues or activity considered likely to compromise an information asset to management as soon as it becomes known
- You are expected to take responsibility for developing an adequate level of information security awareness, education, and training to ensure the appropriate use of Annalise-AI's information assets; and
- You must protect the confidentiality, integrity and availability of Annalise-AI's information in accordance with the information classification levels outlined in the Information Classification Policy
Minimum Qualifications & Experience
- 3-8 years minimum experience working with Quality Systems in relevant development/manufacturing industry.
- Bachelor’s degree in Medical Technology, Software Engineering, or Sciences or BioEngineering
- Quality Systems experience - like ISO 13485 or similar
Preferred
- Experience in Quality System in Medical Device field
- Experience working in Software as Medical Device industry
- Moderate to advanced computer skills, including MS Office apps, Atlassian apps
We are looking for some one with great eye for detail and drive towards improvement orientation.
