QMS Team Lead

April 6, 2025
Reference key: ES13660
Permanent
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Galway city

QMS Team Lead required by leading MedTech company in Galway to play a critical role in managing and continuously improving the Quality Management System (QMS). You will ensure that products meet rigorous standards, including ISO 13485, FDA QSR and MDSAP. Leading a team of System Engineers and Data Systems Analysts, you’ll support compliance, audits and help drive the continuous improvement of quality processes.

REQUIREMENTS:

  • Bachelor’s Degree in Engineering, Science, Quality Management, or a related field.

  • 7+ years of experience in a regulated device or pharmaceutical industry, with a strong understanding of ISO and FDA requirements.

  • Certification in Quality Management (e.g., ISO 9001 Lead Auditor) is preferred.

  • Proven experience maintaining a QMS and conducting internal audits.

  • Strong leadership experience with 3+ years in managing people in a growing company.

  • Excellent analytical, problem-solving, and communication skills.

  • Strong emotional intelligence and a focus on mentoring and developing employees.

RESPONSIBILITIES:

  • QMS Implementation: Support the further implementation of eQMS in collaboration with Program Managers and Subject Matter Experts (SMEs).

  • Quality Management System Maintenance: Ensure ongoing development and maintenance of QMS in compliance with ISO 9001 and other relevant standards.

  • Risk Management: Develop and maintain quality risk management processes, ensuring improvements are made in line with internal feedback.

  • Audits & Certifications: Facilitate ISO 9001 external certification assessments, manage internal audits and ensure audit readiness across departments.

  • Continuous Improvement: Analyze quality metrics, identify areas for improvement, and drive cross-functional quality improvement initiatives.

  • Team Leadership: Lead and support a team to ensure effective coordination and collaboration across departments.

  • Training & Development: Provide ongoing quality training to employees and new hires, ensuring they are informed on compliance requirements and standards.