Quality & Validation Engineer — Flexible Work & Career Growth

Mergon Group; Castlepollard; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

26 days holidays

Career Growth and Development Opps

Company Gym

Wellness Programme

Employee Assistance Programme (EAP)

Job summary

Mergon Group is seeking a Quality & Validation Engineer in Ireland to support QA and validation activities, ensuring high-quality systems and regulatory compliance. The role includes executing validation protocols, data analysis, and driving investigations for deviations and CAPAs.

The candidate will contribute to ISO 13485 and ISO 9001 compliance, participate in internal audits, and support new product development and production trials with a focus on continuous improvement.

Qualifications

• Ordinary Degree in Science, Engineering or a related field.
• Minimum 2 years experience in quality within an ISO 13485 environment.
• Internal Auditor qualified to ISO 13485 is preferred.
• Strong interpersonal, problem solving and attention to detail skills.
• Experience with equipment validation and statistical analysis is desirable but not essential.
• Proficient computer skills.

Responsibilities

• Provide QA support to ensure the Quality System meets high standards focusing on validations and non-conformances.
• Write and execute validation protocols and reports for new products and revalidations (IQ, DOE, Stability, OQ, PQ).
• Carry out data analysis on validation data and prepare reports with recommendations.
• Ensure traceability and audit readiness for internal and regulatory audits/inspections.
• Support investigations and closure of Validation Deviations and CAPAs.
• Assist with maintaining the quality system to ISO 13485 and ISO 9001 standards, and support SOP creation and revisions.

Skills

Interpersonal skills

Problem solving

Attention to detail

Proficient computer skills

Statistical analysis

Education

Ordinary Degree in Science/Engineering

Job description

Mergon Group is seeking a Quality & Validation Engineer in Ireland to support QA and validation activities, ensuring high-quality systems and regulatory compliance. The role includes executing validation protocols, data analysis, and driving investigations for deviations and CAPAs.

The candidate will contribute to ISO 13485 and ISO 9001 compliance, participate in internal audits, and support new product development and production trials with a focus on continuous improvement.