Quality Leader: GMP/ISO Compliance, Audits & QMS

CareerWise Recruitment

Galway

On-site

EUR 65,000 - 90,000

Full time

3 days ago
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Job summary

CareerWise Recruitment is seeking a Quality Lead to head a team of inspectors in Galway, Ireland. You will ensure adherence to SOPs and GMP/GDP, drive audit readiness, and manage QMS processes across ISO standards.

The role requires strong leadership, audit experience, and data-driven quality improvement. The successful candidate will oversee daily planning, maintain housekeeping standards, and report quality KPIs while coordinating with stakeholders and customers to ensure quality objectives

Qualifications

  • NFQ Level 7 qualification in Quality, Engineering, or related discipline.
  • Minimum 5 years’ experience in Quality or Manufacturing Engineering in a regulated manufacturing environment.
  • Minimum 4 years’ supervisory/people management experience.
  • Strong working knowledge of ISO standards (preferably ISO 13485) and quality systems.
  • Experience managing audits (internal, customer, and supplier).
  • Proven experience in document control and QMS processes.

Responsibilities

  • Lead, supervise, and develop a team of Quality Inspectors to ensure consistent application of quality standards.
  • Plan and allocate daily work, ensuring adequate coverage aligned to production requirements.
  • Ensure all inspection and quality activities are performed in accordance with SOPs, work instructions, and GMP/GDP requirements.
  • Lead and support internal, external, customer, and supplier audits.
  • Ensure audit readiness and drive timely closure of audit findings.
  • Maintain and support the Quality Management System (QMS), ensuring ISO compliance.
  • Act as escalation point for quality issues and communicate with stakeholders and customers.
  • Analyse quality data and trends to identify improvement opportunities and reduce defects, scrap and rework.
  • Ensure accurate and timely reporting of quality metrics and KPIs.
  • Maintain high standards of housekeeping (5S/6S) within quality areas.

Skills

Quality leadership
People management
Audit management
GMP/GDP/compliance
ISO standards knowledge
Data analysis

Education

NFQ Level 7 in Quality or Engineering

Tools

QMS systems

Job description

CareerWise Recruitment is seeking a Quality Lead to head a team of inspectors in Galway, Ireland. You will ensure adherence to SOPs and GMP/GDP, drive audit readiness, and manage QMS processes across ISO standards.

The role requires strong leadership, audit experience, and data-driven quality improvement. The successful candidate will oversee daily planning, maintain housekeeping standards, and report quality KPIs while coordinating with stakeholders and customers to ensure quality objectives

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