4 of 4 ISO 13485 Jobs in the South East

service -- building and maintaining the in-house clinical and healthcare software that supports patient care across the Trust, all within the framework of an ISO13485-certified Quality Management System. This is a hands-on technical leadership role; therefore, if you love writing good quality code and also enjoy shaping … client and server environments Establishing and maintaining robust design, version control, and quality assurance practices for in-house systems, in line with the ISO 13485 QMS Designing, building, and supporting the data layer behind our clinical software, working across both relational and non-relational databases Troubleshooting complex software ...

Quality Assurance within the medical device industry. Strong knowledge of medical device design, development and Quality Management Systems (QMS). Working knowledge of ISO 13485, FDA 21 CFR Parts 820 & 11, and EU MDR (2017/745). Experience leading internal, external and regulatory audits. Understanding of risk … management principles (ISO 14971 desirable) and regulatory compliance requirements. Proven ability to lead CAPA and root cause investigations using recognised problem-solving methodologies. Experience driving continuous improvement and implementing quality improvement initiatives. Strong leadership, communication and stakeholder management skills, with the ability to influence cross-functional teams. Excellent analytical ...

help monitor budget spend against timelines. Risk & Compliance Awareness: Support the team in ensuring project documentation strictly adheres to global regulatory standards (e.g., FDA, ISO 13485, GMP). Flag early risks or bottlenecks to senior leads. Stakeholder Communication: Maintain action logs, prepare progress updates, and assist with draft ...

continuous improvement initiatives. What We Are Looking For Regulated Industry Experience: Experience working within a strictly regulated environment (highly prefer medical devices under ISO 13485/FDA 21 CFR Part 820, though Pharmaceuticals or Aerospace will be considered). Validation Background: Proven track record as a Validation Engineer ...