Senior Quality Engineer

Gi Group; Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

Gi Group in Limerick is seeking a Senior Quality Engineer to lead risk management, validation, and process improvements within a medical device manufacturing environment.

The role focuses on driving quality systems, supporting product development, and ensuring regulatory compliance. You will guide cross-functional teams, implement Lean Six Sigma projects, and mentor engineers to advance quality and manufacturing excellence in a fast-paced facility.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or related engineering field.
• Minimum 5 years' experience in medical device manufacturing or a similarly regulated environment.
• Strong experience with risk management documentation (FMEA, pFMEA, dFMEA).
• Proven experience in validation (process, equipment, product).
• Solid knowledge of statistics and data-driven decision making.
• Proficiency with MS Office; CAD experience is an advantage.
• Excellent communication, documentation, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead and maintain risk management documentation including FMEAs, hazard analyses, and risk files.
• Drive process optimisation and continuous improvement using Lean and Six Sigma methodologies.
• Support and lead validation activities (IQ/OQ/PQ, process validation, equipment qualification) with strong statistical justification.
• Develop and update work instructions, training materials, and technical documentation for production and project teams.
• Provide technical guidance, coaching, and support to technicians and junior engineers.
• Collaborate cross-functionally with Manufacturing, R&D, Quality, and Operations to resolve issues and support project delivery.
• Represent Quality Engineering in project meetings, audits, and cross-functional initiatives.

Skills

Risk management

Process improvement

Statistical analysis

Project leadership

Communication

Documentation

Education

Bachelor's degree in Mechanical, Biomedical, or related engineering

Tools

MS Office

CAD

Job description

Senior Quality Engineer
Location: Limerick
Contract: 12 Month Fixed Term

About the Role

Gi Group Recruitment are seeking an experienced Senior Quality Engineer to join our high‑performing medical device client based in Limerick.
Our client is a global leader in life‑saving medical technologies. Engineers here work in a mission‑driven environment where every improvement directly impacts patient outcomes. They are renowned for their world‑class facilities, strong career development, and the opportunity to contribute to innovative products used in hospitals worldwide.
This role is ideal for a quality professional who enjoys project ownership, driving process improvements, and influencing product and manufacturing quality at a strategic level.
You will apply strong engineering, validation, and risk management expertise to support product development, optimise manufacturing processes, and ensure compliance with regulatory and quality system requirements.

Why Join Us?

• Join a mission‑driven organisation where your work directly improves and saves patient lives.
• Work in a world‑class manufacturing facility with cutting‑edge technologies and global engineering standards.
• Collaborate with highly skilled cross‑functional teams across Quality, R&D, Manufacturing, and Operations.
• Gain exposure to complex investigations, advanced quality tools, and high‑impact engineering projects.
• Build your expertise in risk, validation, continuous improvement, and problem solving.
• Strong opportunities for career progression into senior, technical specialist, or leadership roles.
• Extremely competitive remuneration package

Key Responsibilities

• Lead and maintain risk management documentation including FMEAs, hazard analyses, and risk files.
• Drive process optimisation and continuous improvement using Lean and Six Sigma methodologies.
• Support and lead validation activities (IQ/OQ/PQ, process validation, equipment qualification) with strong statistical justification.
• Develop and update work instructions, training materials, and technical documentation for production and project teams.
• Provide technical guidance, coaching, and support to technicians and junior engineers.
• Collaborate cross‑functionally with Manufacturing, R&D, Quality, and Operations to resolve issues and support project delivery.
• Represent Quality Engineering in project meetings, audits, and cross‑functional initiatives.

Requirements

• Bachelor's degree in Mechanical, Biomedical, or related engineering discipline.
• Minimum 5 years' experience in medical device manufacturing or a similarly regulated environment.
• Strong experience with risk management documentation (FMEA, pFMEA, dFMEA).
• Proven experience in validation (process, equipment, product).
• Solid working knowledge of statistics and data‑driven decision making.
• Proficiency with MS Office; CAD experience is an advantage.
• Strong communication, documentation, and stakeholder management skills.
• Ability to manage multiple priorities in a fast‑paced environment.
• Experience leading or supporting engineering projects.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience redesigning or improving manufacturing processes, equipment, or fixtures.

KSGalway

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, corporate members for Neurodiversity in business, Disability Confident committed members, Gold status for the Armed Forces Covenant, Bronze trail blazers for Racial Equality matters and Age Friendly Employer pledge members.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Business in relation to this role.

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