Quality Engineer

Oxford Global Resources; Galway; On-site; EUR 50,000 - 70,000; Full time

Job summary

Oxford Global Resources in Galway seeks an experienced Quality Engineer to support day-to-day line management and NCR/CAPA activities on-site with our client in the med-tech sector. You'll work with quality engineers and technicians to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready, including IQ/OQ/PQ support and process validation.

The role requires 3–5 years of med-tech quality experience and strong technical writing skills, with

Qualifications

• 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.

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 / NCR management

Technical writing

Regulatory knowledge

Education

Engineering or Quality degree

Job 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.