Project Quality Engineer
Leeds, West Yorkshire
£Negotiable plus benefits.
My client, based in the heart of West Yorkshire within walking distance of Leeds City Centre and commutable distance to some of the most beautiful rural areas of the country, are a national and recognised leader in the design and manufacture of surgical devices used in ENT, General Surgery and Laser procedures.
As the UK’s leading designer and manufacturer of these innovative medical device products this well-established company now have a requirement for a Project Quality Engineer to take NPI (New Product Introduction) projects from the concept design stage, through to manufacture plus ensuring appropriate quality plans are included in all stages of the product life cycle and also ensuring that products meet all regulatory requirements.
As a Project Quality Engineer you will be responsible for.
* The development and integration of new production technologies to support new and existing business from product concept through to end of product life.
* RCA (Root Cause Analysis) problem solving duties in order to identifying root cause of faults or problems.
* Product and process Validation and Verification - including IQ / OQ / PQ, DOE and TMQs.
* Supporting regulatory submission for multiple projects including Risk Management Plan, FMEAs and standard reviews.
* Planning and monitoring new and existing product testing.
* Continuous improvement activity.
* Reviewing product design with regard to manufacturing feasibility, using Solidworks.
* Working to ISO 13485, 9001 and 14971 standards.
* Working with departments throughout the company and offering expertise on DFM (Design for Manufacture) issues.
Applications are invited from people with experience / knowledge of Project Quality Engineering from the medical device industry who have the ability to take products from concept design stage to SOP (Start of Production). This may be a great opportunity for Science Graduates with one or two year’s relevant experience.
In return my client will offer a very competitive and negotiable salary, pension, life assurance, free parking, a first rate development and training programme plus excellent prospects for advancement within this successful, national and well established organisation.
If you feel you have the necessary skills, experience and drive please email your CV
New Product Development
Continuous Improvement Process