Design Quality Engineer – Onsite in Limerick (4 days)

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 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