Quality Engineer

RED Global; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

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

The ideal candidate will bring hands-on Design Quality experience in regulated product development, with strong risk management and the ability to challenge designs across multiple SMEs. A solid understanding of ISO 13485 and EU MDR is essential.

Qualifications

• Hands-on Design Quality experience in regulated development.
• Strong knowledge of ISO 13485 and EU MDR requirements.
• Experience with design controls, V&V, risk assessments, and change control.
• Able to collaborate with SMEs and ensure traceability of design history files.

Responsibilities

• Support design controls throughout product development lifecycle.
• Review design inputs/outputs, requirements and specifications.
• Lead/design risk management activities including DFMEA/FMEA and hazard analysis.
• Ensure risks and controls are linked to design requirements and V&V.
• Maintain Design History Files and cross-functional communication with SMEs.

Skills

Design Quality

Risk Management

ISO 13485

EU MDR

Design Controls

V&V

Medical Device Industry

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
• 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.