Staff Design Quality Engineer

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Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Galway, Ireland

Job Description:
We are searching for the best talent for a Lead Design Quality Engineer.

Purpose

We are looking for a Lead Design Quality Engineer to join our MedTech Neurovascular team in Galway, Ireland.

In this role, you will provide Design Quality technical and compliance expertise to support new product development, design changes, and lifecycle management activities.

Working closely with Product Development, Regulatory Affairs, Manufacturing, and other multi-functional teams, you will help ensure products are developed and maintained in compliance with applicable regulations and company requirements.

This role provides leadership in Design Control, Risk Management, and Quality System activities, supporting product development from concept through commercialization and post-launch activities.

You will be responsible for

In this role, you will lead Design Quality activities supporting new product development and lifecycle management programs.

You will work closely with R&D and multi-functional partners to ensure Design Control and Risk Management requirements are applied effectively and consistently throughout product development and manufacturing processes.

You will provide guidance on global medical device regulations and help teams interpret and apply Design Control and Risk Management requirements to support compliant product development and commercialization activities.

Key responsibilities include:


* Leading Design Control and Risk Management activities to ensure compliance with applicable quality system requirements


* Partnering with R&D teams to support new product development and product lifecycle management activities


* Leading Design Quality activities associated with product launches and design transfer programs


* Guiding product development teams in the effective application of Design Control and Risk Management processes


* Supporting identification of design inputs, development of design outputs, failure mode prevention activities, and verification and v...