|Job title :||Senior Quality Engineer (Design Control)|
|Location :||Republic of Ireland|
|Job type :||Contract/Freelance|
|Salary :||€50000 - €55000 per annum|
|Contact name :||John Spring|
|Contact email :||firstname.lastname@example.org|
A great opportunity with a market-leading medical diagnostics organisation has arisen, with an opportunity to play a key role in the company's R&D QA Division where you will be responsible for design change and innovation projects. Initially this is a project until the end of 2020, with a strong likelihood to extend throughout 2021.
Salary & Benefits:
€55k pro rata. Full details on request (opportunity open to
Role and responsibilities:
*Reviewal of design projects throughout the Design Control process for compliance and ensuring of compliant closure of Design History Files (DHFs).
*Support the Design Control Process, including design change.
*Reviewal and approval of validation protocols (equipment validation, utilities, process validation, cleaning validation, test method validation and software) and final validation reports ensuring compliance to all SOPs and WIs
*Updating of Design Control and R&D procedures/systems
*conduct internal audits, ensuring compliance of R&D and technical areas (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements.
*Risk Management specialisation
*Complete reports on post market surveillance
Requires skills and qualifications:
*Scientific Degree with 2 years' industry experience (Doctorate level), 3 years' industry experience (Master's level) or 5 years' industry experience (Bachelor's level)
*Experience in a highly regulated (FDA desirable) healthcare or related environment
*Experience in IVDDs, Design Controls and/or Risk Management
To apply for this position and put yourself under immediate consideration, send your CV to email@example.com or call +44 (0) 207 255 6650