Quality Engineer Design Assurance Limerick


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

2nd February 2021

Location

Limerick

Salary/Rate

£49698 - £50602

Type

Permanent

This job has now expired please search on the home page to find live IT Jobs.

Due to ongoing growth a client of ours in Limerick are expanding their quality team and have several vacancies live to join them on a permanent basisThe ideal candidate will have a minimum level 8 degree in related discipline, with a minimum of 5 years of relevant experience and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485, 21CFR820) and have experience working in the medical device sector.Some of your main responsibilitiesBe Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .Lead risk management activities within the project.Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.Ensure process validation activities are completed appropriately and make the link with product design whenever needed.Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.Conduct quality functional reviews and DHF compliance reviews.Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485 / MDSAP certificationCoordinate quality data consolidation and reporting on Key Performance Indicators (KPIs) in order to drive continuous improvement across QMS.Qualifications/ExperienceAdditional experience with Class III combination devices in a cleanroom environment, Capital equipment validation and reliability testing would be a distinct advantage.The ability to collect data, analyze situations and propose optimal process solutions to meet both Compliance and Business requirements.An individual in this role must have proven leadership, communication, organization and project management skills with a strong orientation on processes.The ability to communicate efficiently in an international environment with internal / external customers and key stakeholders. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

You are currently using an outdated browser.

Please consider using a modern browser such as one listed below: