Quality Engineer | GMP, Validation & Regulatory Compliance

Vital Healthcare; Connacht; On-site; EUR 55,000 - 80,000; Full time

Job summary

Vital Healthcare seeks a Quality Engineer for its Galway manufacturing site to provide quality support and oversee validations, monitoring and calibration activities in line with GMP and regulatory standards.

The role requires a science-based qualification and experience in a regulated manufacturing environment, with a focus on quality systems, risk management and audits. Travel to supplier sites may be required.

Qualifications

• Bachelor's degree or higher in science, quality or related discipline.
• Experience in regulated manufacturing environments (GMP/GDP) and quality systems.
• Familiarity with EU IVDR/MDR and ISO 13485 is advantageous.

Responsibilities

• Provide quality support to site departments and maintain Quality Management System.
• Ensure compliance to GMP, EU IVDR, and regulatory requirements.
• Support regulatory inspections, customer and internal audits.
• Develop and maintain SOPs, validation protocols, risk assessments, and technical files.
• Oversee equipment qualification, validation and calibration activities.
• Drive continuous improvements across site manufacturing and quality systems.

Skills

Quality management

Regulatory compliance

Project management

Auditing (advantage)

Cross-functional collaboration

Education

Science degree (third level)

Job description

Vital Healthcare seeks a Quality Engineer for its Galway manufacturing site to provide quality support and oversee validations, monitoring and calibration activities in line with GMP and regulatory standards.

The role requires a science-based qualification and experience in a regulated manufacturing environment, with a focus on quality systems, risk management and audits. Travel to supplier sites may be required.