| Employment Type | Permanent |
|---|---|
| Location | Middlesex, |
| Industry Sector | Mechanical |
| Start Date | |
| Salary/Rate | 28000 |
| Reference | 8400C7E7 |
| Date Advertised | 02-07-2008 - 00:00 |
Design Quality Engineer - Middlesex
Electrical and electronic hardware design, project m...
Design Quality Engineer - Middlesex
Electrical and electronic hardware design, project management, documentation and department administration duties.
Duties:
Responsible for ensuring the Company meets the requirements of its ISO 9000 registration including regular auditing, supervision of regular Quality meetings and preparation and administration for the biannual external audits.
Responsible for ensuring the Company fulfils the regulatory requirements for the MHRA approval of its products, including regular auditing, liaising with the MHRA and the associated notified bodies, and maintaining product documentation in accordance with the regulatory requirements.
Responsible for ensuring the Company fulfils the regulatory requirements for the FDA approval of its products, including regular auditing, liasing with the FDA and maintaining product documentation in accordance with the regulatory requirements.
Providing support to the Design department for product validation, including the generation and implementation of product validation plans.
Providing support to the Design department for product documentation, including Technical Construction Files and User Guides.
General maintenance of the Quality procedures.
Quality - this would normally be done by the manager concerned, It does include giving advice on how to write procedures to comply with the requisite quality standards.
Preparation for the monthly quality meeting
Management of the Defect Reporting system.
Work on hardware design of company products as instructed and to agreed project plans.
Design of experiments and evaluation testing of prototypes and production equipment including compliance testing to national and international standards.
The company is approved to ISO 9001:2000, ISO13485:2003 and is also assessed to the demanding Medical Devices Directive, Annex 11 93/42/EEC standard.
