Quality Engineer

Oxford Global Resources

Galway

On-site

EUR 50,000 - 65,000

Full time

2 days ago
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Job summary

Oxford Global Resources seeks an experienced Quality Engineer for an on-site Galway role supporting day-to-day line management, non-conformances, CAPA closure, and regulatory readiness. You will collaborate with quality technicians and process owners to close gaps, validate processes (IQ/OQ/PQ), and ensure documentation stays audit-ready in a med-tech environment.

This is a fixed-term, 12-month contract with extension opportunities; full-time, on-site, Galway, and requires 3–5 years' med-tech

Qualifications

  • Engineering or quality degree required.
  • 3–5 years med-tech experience.
  • Knowledge of 21 CFR Part 820 and ISO 13485.
  • Strong technical writing skills.

Responsibilities

  • Partner with process owners and quality technicians on the floor to capture and remediate issues.
  • Support process validation (IQ/OQ/PQ) and documentation updates.
  • Drive CAPA/NCR closure and implement compliant solutions.
  • Provide technical writing for quality and manufacturing documents.
  • Collaborate cross-functionally to ensure regulatory compliance.

Skills

Quality engineering
CAPA management
Technical writing
Regulatory compliance

Education

Engineering or Quality degree

Job description

PROJECT DESCRIPTION

Our client in Galway are seeking an experienced Quality Engineer to support their operations, focusing on day-to-day line management and non-conformances. The successful candidate will be based on-site and work directly with other quality engineers and technicians to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.

RESPONSIBILITIES
  • Partner with process owners and quality technicians on the floor to capture and remediate issues.
  • Support process validation (IQ/OQ/PQ) and documentation updates.
  • Drive CAPA/NCR closure and implement compliant solutions.
  • Provide technical writing for quality and manufacturing documents.
  • Collaborate cross-functionally to ensure regulatory compliance.
REQUIREMENTS
  • Engineering or Quality degree with 3–5 years’ med-tech experience
  • Background in remediation, CAPAs, NCRs.
  • Strong technical writing and documentation skills.
  • Knowledge of 21 CFR Part 820, ISO 13485.

FIXED TERM CONTRACT

12 MONTHS WITH AN EXTENSION

SALARY

PENSION

HEALTHCARE

HOLIDAYS

FULL TIME ONSITE IN GALWAY

MEDTECH EXPERIENCE REQUIRED

3 - 5 YEARS EXPERIENCE REQUIRED

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