Quality Technician

Quality Technician

CREGG are hiring for a Quality Technician for a leading Medical Device Company in Galway. 

For more information contact mark: 086 190 1346 or [email protected]
 

Job Summary

The Quality Control Inspector is responsible for ensuring that products meet established quality standards and regulatory requirements throughout the manufacturing process. This role supports compliance with ISO 13485, FDA QSR (21 CFR Part 820), and EU Medical Device Regulations (MDR), while contributing to continuous improvement and patient safety.

Key Responsibilities

• Perform incoming, in-process, and final inspections of medical device components and finished products

• Conduct visual, dimensional, and functional inspections using appropriate measuring equipment (e.g., calipers, micrometers, gauges, optical comparators)

• Review and interpret engineering drawings, specifications, and inspection plans

• Accurately document inspection results in accordance with GMP and company procedures

• Identify, document, and report non-conformances; support investigations and corrective actions (CAPA)

• Ensure compliance with ISO 13485, FDA, EU MDR, and internal quality system requirements

• Support lot release activities and ensure traceability of inspected materials

• Participate in audits (internal, customer, and regulatory) as required

• Maintain inspection equipment and ensure calibration status is up to date

• Contribute to continuous improvement initiatives within the Quality function

• Adhere to health, safety, and environmental requirements at all times

Requirements & Qualifications

Essential:

• Leaving Certificate or equivalent qualification (FETAC/QQI Level 5 or higher preferred)

• Minimum 1–3 years’ experience in a Quality or Inspection role within a regulated manufacturing environment (medical device, pharmaceutical, or life sciences preferred)

• Strong understanding of GMP and quality systems

• Ability to read and interpret technical drawings and specifications

• High attention to detail and strong documentation skills

• Good written and verbal communication skills

• Ability to work independently and as part of a team

  INDTRAC