Quality Technician

GxP Recruitment; Galway; On-site; EUR 42,000 - 54,000; Full time

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

Are you looking to grow your career as a Quality Technician and work with a leading medical device client in Galway?

Shift: 07.00am -19.00pm - Thurs/ Fri / Sat / Sun one week and Fri , Sat, Sun subsequent week.

You will support operations, playing a key role in ensuring the quality, compliance, and integrity of manufacturing processes. This role involves processing and analysing non-conformance events, supporting internal and external audits, reviewing and managing quality documentation, and working collaboratively with cross‑functional teams to ensure ongoing product quality.

Essential Duties and 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 led by Quality Engineers.
• Support production through regular presence on the manufacturing floor and assist the inspection team with questions related to inspection methods, processes, and specifications.
• Support Quality Engineering in ensuring compliance with internal procedures and external standards and regulations, including GMP, GLP, ISO, and Six Sigma requirements.
• Update and maintain quality assurance procedures, protocols, and methods for processing materials into partially finished and finished products.
• Ensure manufacturing and production processes comply with internal quality systems and applicable safety, quality, and regulatory requirements to enable worldwide product distribution.
• Support the investigation, assessment, verification, and disposition of nonconforming materials in collaboration with cross‑functional teams.
• Perform routine line audits to verify that systems are compliant, effective, and operating as intended.

Background:

• Demonstrate 2–4 years of experience working effectively in a medical device or similarly regulated manufacturing environment, applying quality systems with confidence and consistency.
• Strong shop‑floor presence and ownership of assigned quality systems, proactively engaging with Operations to support compliance and real‑time issue resolution.
• Contribute to non‑conformance investigations and CAPA activities through timely assessment, effective collaboration, and thorough documentation.
• Maintain audit‑ready behaviours at all times, with a clear understanding of FDA, ISO, and MDSAP requirements and the ability to support inspections and audits confidently.
• Demonstrate sound judgement and confident decision‑making, taking ownership of issues while knowing when and how to elevate appropriately.
• Work effectively both independently with minimal supervision and collaboratively within cross‑functional teams to achieve quality and operational objectives.