Quality Engineer

RED are working with a global Life Sciences Company to hire a couple of Design Quality Engineers on a permanent basis.

This role will require 4 days per week onsite in County Limerick. The days per week is non-negotiable for this position.

The client are looking for hands-on Design Quality Engineers with strong skills in Risk Management. Someone who can challenge designs, identify, and mitigate risks; someone who can operate across multiple SME's within the business and provide advice and support across a number of areas of design quality.

Key Responsibilities:

• Support Design Controls throughout the product development lifecycle
• Review and challenge design inputs/outputs, requirements and specifications
• Lead/support Design Risk Management, including DFMEA/FMEA, hazard analysis, risk assessments, risk controls and mitigation activities.
• Ensure risks and associated controls are appropriately linked to design requirements and V&V activities.
• Maintain appropriate design documentation, traceability and Design History Files.
• Work as a key connection point between Engineering and specialist SMEs, providing an all-round design quality and risk perspective

The Ideal Candidate Will Have:

• Strong Design Quality / Design Assurance experience within regulated product development
• A good understanding of ISO 13485 regulations and EU MDR requirements
• Strong experience across design controls, V&V, risk management, and design change control

Someone from an automotive or medical device background would excel in this role, deep software, cloud or connected-device experience is not essential, as the device is not heavily digitally connected.

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