Quality Engineer - GMP, Validation & Compliance

Vital Healthcare; Galway; On-site; EUR 50,000 - 70,000; Full time

Job summary

Vital Healthcare in Galway (Fannin LIP Galway) is seeking a Quality Engineer to provide quality support across the site, overseeing validations, monitoring, and calibration to ensure compliance with GMP and regulatory standards.

The role involves maintaining quality systems, supporting regulatory inspections and audits, managing validation activities (IQ/OQ/PQ), risk assessments, and document control, with scope to lead improvement projects and collaborate across departments.

Qualifications

• Relevant third level qualification in science, quality or a related discipline (microbiology or validation qualification is an advantage)
• Experience in a regulated manufacturing environment, EU IVDR, EU MDR, GMP/GDP, and quality management systems (ISO 17025/ISO 9001/ISO 13485)
• Experience with medical device risk management in accordance with ISO 14971 is preferable
• Experience in supporting validation activities (IQ/OQ/PQ), change management and non-conformance investigations
• Demonstrated project management experience
• Auditor certification is an advantage

Responsibilities

• Provide quality support to the various departments across the site to ensure effective maintenance and implementation of the Quality management Systems.
• Ensure compliance to GMP, EU IVDR, and applicable regulatory requirements.
• Support regulatory inspections, customer audits, and internal quality audits.
• Develop, maintain, and ensure implementation of in-house documents (SOPs, Validation Protocols, Risk Assessments, technical files).
• Support issues management (Complaints, Vigilance activities)
• Oversee equipment qualification, validation and calibration activities for the site to ensure GMP compliance.
• Oversee onsite monitoring systems operations.
• Perform QA activities to ensure raw materials and finished products meet quality and safety standards.
• Support site-level quality risk management and documentation.
• Drive continuous improvements across site manufacturing, maintenance, and quality systems.
• Lead quality-related projects as assigned by Site Quality Manager.

Skills

Quality management

GMP

Auditor certification

Project management

Regulatory compliance

Education

Third level qualification in science/quality

Job description

Vital Healthcare in Galway (Fannin LIP Galway) is seeking a Quality Engineer to provide quality support across the site, overseeing validations, monitoring, and calibration to ensure compliance with GMP and regulatory standards.

The role involves maintaining quality systems, supporting regulatory inspections and audits, managing validation activities (IQ/OQ/PQ), risk assessments, and document control, with scope to lead improvement projects and collaborate across departments.