9 of 9 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 ...

Head Office in Basingstoke. What will you be doing? As Quality Assurance Engineer , you will provide Quality Assurance support to our Quality Management System (ISO13485:2016) whilst assisting meeting our Regulatory responsibilities. This role is offered on a hybrid basis, with the expectation of 3-4 days onsite per week. … duties: Supporting the Implementation, maintenance, continuous improvement, and support of Blatchford's Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaborating across internal departments to provide Quality Assurance support. Participating in external Quality aud it activities . R epresenting QA for various projects across ...

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 ...

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 ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

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 ...