Principal Software Quality Engineer

HRS are working with a Biotechnology company whose innovative technology is helping to change the lives of cancer patients. Through their ground-breaking developments in non-invasive diagnostic products, they help detect cancer at the early stage & help monitor treatment & recovery.

Based in Cambridge, we are seeking to hire a Principal Quality Software Engineer to help drive the development of SaMD processes to ensure the best quality software products are used in clinical practise. This will be an integral position that will be based out of Cambridge but will also collaborate with international sites & colleagues based in the USA.

Working alongside an international team, your duties as the Principal Software Quality Engineer will include:

1. SaMD Quality Engineering for software product components & systems.
2. Ensuring software development & testing procedures meet all regulatory requirements, including ISO 13485 / 62304.
3. Working closely with QA teams to update & create SOPs for software QA, SDLC & related processes.
4. Contribute to technical design and project phase reviews.

To be successful in your application to this exciting opportunity as the Principal Software Quality Engineer we are looking to identify the following on your profile and past history:

1. Relevant degree or proven equivalent experience in Computer Science, information systems, software engineering or similar.
2. Proven industry experience in software QA, including experience in Software as a Medical Device, in line with global ISO standards (ISO 13485, ISO14971, IEC62304)
3. A working knowledge and practical experience with GAMP5/GxP, US Regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, 21 CFR 211), UK EU Regulations (European Union in Vitro Diagnostic Device Directive (IVDD)/ in Vitro Diagnostic Regulation (IVDR)).