Quality Engineer II
Kelly Services Ireland ·www.gigroup.ie
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Title: Quality Engineer II
Location: Limerick
Contract: 12 Month Fixed Term
Summary: Gi Group Recruitment are seeking a highly skilled Quality Engineer II to support our client based in Limerick City on a contract basis. 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 with strong analytical capability, exceptional problem‑solving skills, and proven experience driving CAPA, RCA, and complaints investigations in a highly regulated medical device environment. This position offers significant cross‑functional exposure and the opportunity to influence product and process performance at a high level.
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
- Possibility of a 4 day work week promoting a strong and healthy work/life balance
Responsibilities:
- Provide direct line support by responding to manufacturing issues, troubleshooting problems, and ensuring production continuity.
- Lead and support Root Cause Analysis (RCA) using structured methodologies (5‑Why, Fishbone, Fault Tree, DMAIC etc.).
- Drive CAPA ownership, ensuring investigations are thorough, data‑driven, and closed with effective long‑term solutions.
- Conduct and support complaints investigations, linking field performance to manufacturing processes and risk documentation.
- Partner with Engineers to implement line improvements focused on yield, throughput, cycle time, and defect reduction.
- Support rollout of new fixtures, equipment, and process changes by executing validation activities (IQ/OQ/PQ).
- Analyse data using statistical tools to identify trends, validate hypotheses, and support decision‑making.
- Collaborate cross‑functionally with Manufacturing, Quality, R&D, and Operations to resolve issues and drive continuous improvement.
- Prepare clear, structured documentation including investigation reports, validation protocols, and technical summaries.
Requirements:
- 5+ years’ experience working on a medical device manufacturing line or in a regulated quality engineering role.
- Strong experience in problem solving, RCA, and CAPA with a proven track record of delivering effective corrective actions.
- Experience supporting or leading complaints investigations.
- Solid understanding of validation (process, equipment, product).
- Strong working knowledge of statistics and data analysis tools.
- 3rd‑level qualification in engineering or science (or equivalent experience) is highly desirable.
- Excellent communication skills with the ability to work across multiple functions and influence stakeholders.
- Demonstrated ability to identify issues, analyse data, and propose practical solutions.
- Proficiency with Microsoft Office.
Desirable
- Experience with Six Sigma methodologies; Green Belt or Black Belt is a strong advantage.
- Strong understanding of manufacturing metrics, line dynamics, and continuous improvement tools.
KSGalway
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Should you require any support or assistance, please contact your local Gi Group office.
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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