Quality Engineer II - MedTech, RCA/CAPA, 4-Day Week

Gi Group; Limerick; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

4 day work week

Job summary

Gi Group Recruitment in Limerick is seeking a Quality Engineer II on a 12‑month fixed term contract. The role focuses on supporting manufacturing operations in a medical device environment, driving CAPA, RCA, and complaints investigations, and collaborating with cross‑functional teams to improve yield and process performance.

The candidate will analyse data, implement validation activities (IQ/OQ/PQ), and contribute to risk management and continuous improvement initiatives across Quality, R&D,

Qualifications

• Strong analytical capability and problem‑solving skills.
• Proven experience driving CAPA, RCA, and complaints investigations in a highly regulated medical device environment.

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.

Skills

CAPA

RCA

Problem solving

Data analysis

Cross-functional collaboration

Job description

Gi Group Recruitment in Limerick is seeking a Quality Engineer II on a 12‑month fixed term contract. The role focuses on supporting manufacturing operations in a medical device environment, driving CAPA, RCA, and complaints investigations, and collaborating with cross‑functional teams to improve yield and process performance.

The candidate will analyse data, implement validation activities (IQ/OQ/PQ), and contribute to risk management and continuous improvement initiatives across Quality, R&D,