Design Quality Professional
Design Quality Professional - North Dublin
Our client seeks a Design Quality Professional to work in an ISO 13485 and FDA 21 CFR Part 820 IVD product development and manufacturing environment.
You should have experience in product and process quality including support of new product development, sustaining engineering (Design Change) and design transfer, specifically to support a new product introduction. This is an excellent opportunity to work in a leading manufacturing facility. The quality function works cross-functionally with engineering, production and procurement to cover a wide area of responsibilities such as Change Management, Inspections/ Regulatory Audits with respect to design change, product development and design controls, Verification, Validation and Risk Management.
The Dublin site is currently involved in a number of new product introductions, so this is an exciting time to join this team of Quality professionals.
This position is responsible to provide direction in the areas of Design Control & Risk Management to cross-functional teams responsible for new product development, Temporary Manufacturing Deviations (TMD's), and Design Changes to commercial IVD hardware products. As a Subject Matter Expert (SME), the individual must be able to lead Quality Management System improvement projects and training efforts related to any of the elements within Design Controls.
Interested applicants should have:
At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science discipline or similar).
• 5 or more years' relevant experience supporting the development and/or sustaining engineering associated with IVD hardware systems in a regulated environment, with a core appreciation of FDA regulations and specifically the implementation and application of design controls.
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|Contact Interested candidates should forward their CV to firstname.lastname@example.org immediately or call Anthony McLoughlin - Head Office on 01-6321200 for further information.|