6 of 6 ISO 13485 Jobs in the South East

support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. ...

verification. Champion software engineering best practices version control, code reviews, CI, and automation. Support risk management, audits, and continuous improvement in line with ISO 14971 and ISO 13485. Mentor junior engineers and promote high technical and quality standards. Deliver assigned work packages to meet technical, schedule, and quality … medical software. Familiarity with cloud computing or containerisation (Docker, AWS, Azure) for test and data systems. Strong working knowledge of IEC 62304 (software lifecycle), ISO 13485 (QMS), and ISO 14971 (risk management). Experience working with Notified Bodies, FDA, or MHRA on software-related submissions. Strong mentorship ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

other platforms (AWS, GCP) Experience with Jira, Confluence, or similar project management tools Knowledge of compliance frameworks and standards (e.g., GDPR, HIPAA, ISO27001, ISO13485) Key Attributes Strong collaboration skills Willingness to learn and cross-train in new technologies Hands-on approach to exploring new technologies and developing POCs Excellent problem ...

collaboration within a regulated medical software environment. What You'll Do Lead architecture and development of a high-performance iOS app. Work within ISO 13485/IEC 62304 processes and support product validation. Mentor developers and raise engineering standards. Collaborate with AI/ML, backend, product, and design ...