Quality Technician – Medical Devices, GMP/ISO Focus

GxP Recruitment

Galway

On-site

EUR 42,000 - 54,000

Full time

7 days ago
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Job summary

GxP Recruitment in Galway seeks a Quality Technician to support operations in a medical device environment. You will handle non-conformance events, CAPA investigations, audits, and maintain quality documentation, partnering with cross-functional teams to ensure product quality.

The role emphasizes GMP/ISO/MDSAP awareness, on‑the‑floor presence, and ongoing collaboration to keep systems audit-ready. Ideal candidates have 2–4 years in regulated manufacturing and demonstrate sound judgment and

Qualifications

  • 2–4 years of experience in a medical device or similarly regulated manufacturing environment.
  • Strong shop-floor presence and ownership of assigned quality systems.
  • Contribute to non-conformance investigations and CAPA activities.
  • Maintain audit-ready behaviours with FDA, ISO and MDSAP knowledge.
  • Work independently and in cross-functional teams to meet quality and operational goals.

Responsibilities

  • Support Quality Engineering activities, including Change Order processing, Non-conformances Events (NCEs), Nonconforming Material Reports (NCMRs), and CAPA investigations.
  • Collect manufacturing and inspection data and perform inspections to support investigations.
  • Support production through regular presence on the manufacturing floor and assist inspection with inspection methods and specs.
  • Ensure compliance with internal procedures and external standards like GMP, GLP, ISO and Six Sigma requirements.
  • Update and maintain quality assurance procedures, protocols, and methods for processing materials into finished products.
  • Ensure manufacturing processes comply with quality systems and safety and regulatory requirements for worldwide distribution.
  • Assist in investigation, assessment, verification, and disposition of nonconforming materials with cross-functional teams.
  • Perform routine line audits to verify systems are compliant, effective, and operating as intended.

Skills

Quality systems
GMP
ISO
Six Sigma
CAPA

Job description

GxP Recruitment in Galway seeks a Quality Technician to support operations in a medical device environment. You will handle non-conformance events, CAPA investigations, audits, and maintain quality documentation, partnering with cross-functional teams to ensure product quality.

The role emphasizes GMP/ISO/MDSAP awareness, on‑the‑floor presence, and ongoing collaboration to keep systems audit-ready. Ideal candidates have 2–4 years in regulated manufacturing and demonstrate sound judgment and

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