4 of 4 Permanent ISO 13485 Jobs in the South East

middleware. Writing code and algorithms in accordance with good Software practise - Experience of relevant standards and medical device regulations would be beneficial (e.g. ISO 13485, ISO 9001 ISO 14971 and IEC 62304.) Development of test plans and procedures, conducting and accurately documenting the tests at unit … external stakeholders e.g. production, service, sales teams and suppliers. Knowledge, Skills & Experience: Have experience of software development for medical devices or similar within an ISO regulated environment and be able to work to associated regulations such as IEC 62304. Be able to work efficiently with source code management tools. ...

sector . The Quality Assurance (QA) Assistant is responsible for developing, maintaining, and continuously improving the companys Quality Management System (QMS) in line with ISO 9001, customer, and regulatory requirements. This role focuses on system compliance, process improvement, supplier quality management, audit preparation and participation, accurate ERP data management … supporting the achievement of strategic quality objectives. This includes: Supporting the development, maintenance, and improvement of the companys Integrated Management System (IMS) to meet ISO 9001, ISO 14001, customer, and legal requirements. Assisting in planning, conducting, and following up on internal, supplier, and external audits. Monitoring supplier performance ...

execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 - compliant processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead … document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Cross Functional and Stakeholder Integration: Integrate the electronics/software workstream with assay/chemistry, mechanical design ...

Engineer - CMM Programmer , you will have the following: Key skills and experience: Degree or OMC/HNC equivalent Working knowledge of ISO9001, ISO13485 MS Office experience to a minimum of intermediate level Programming Video Measuring Machine (VMM) Good working knowledge of SolidWorks software Strong communicator with good interpersonal Analytical skills ...