A highly professional R&D company is looking for an experienced Quality Engineer to join their multidisciplinary team based just outside of Cambridge. The Quality Engineer will be responsible for the development, evaluation and auditing of Design History Files (DHF) internally as well as ensuring suppliers and sub contract manufacturers are operating to the highest of professional standards.
This role will suit an ambitious professional who will come from a Design and Development background and have a good understanding of New Product Development/Transfer to Manufacture (primarily in the medical sector) and is looking for career advancement and development opportunities.
Quality Engineer job requirements:
- Good degree ( BSc, BEng, MEng etc) in Mechanical Engineering, Production Engineering, Electronics or similar Engineering or Physical Sciences.
- NPD & NPI/Transfer to Manufacture experience in the medical device and/or pharmaceutical manufacturing/development area.
- Experience of submissions to regulatory authorities including EU, US and ROW.
- Experience of working within ISO 13485 quality management system.
- Experienced at developing content for Design History and technical files.
- Experienced at developing content for Risk Management Files including; Plans, Hazard Assessments, Design FMEA, Process FMEA and Risk Reporting.
- Ability to write technical documents in a methodical and timely manner.
- Willingness to communicate/present to clients at all levels.
- Experience in combination devices would be advantageous.
- A technical understanding of electro-mechanical devices is desirable.
In our view it is a cracking company to work for – a variety of fast moving, high tech projects and the chance to work with some of the brightest Engineers & Scientists as well as a lot of training and professional development opportunities.