Quality Engineer

RED Global; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

RED Global is partnering with a global Life Sciences company to hire Design Quality Engineers on a permanent basis in County Limerick, Ireland. The role requires four days per week onsite in Limerick, a non-negotiable onsite arrangement.

The ideal candidate will bring hands-on Design Quality and Risk Management experience including DFMEA/FMEA, with a solid understanding of ISO 13485 and EU MDR. You will collaborate with SMEs across engineering to ensure quality and risk controls throughout

Qualifications

• Strong hands-on Design Quality and Risk Management experience within regulated product development.
• Proven DFMEA/FMEA capabilities and risk-based decision making.
• Solid understanding of ISO 13485 regulations and EU MDR requirements.
• Experience across design controls, V&V, risk management, and design change control.

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 linked to design requirements and V&V activities.
• Maintain Design History Files and design documentation with traceability.
• Act as a connection point between Engineering and SMEs to provide design quality and risk perspective.

Skills

Design Quality

Risk Management

DFMEA

FMEA

V&V

Design Controls

ISO 13485

Job description

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
• Strong hands-on Risk Management capabilities (DFMEA/FMEA)
• 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.