Senior Quality Leader - Medical Devices

Harmonics Recruitment

Shannon

Sur place

EUR 70 000 - 100 000

Plein temps

14 jours+

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Résumé du poste

Harmonics Recruitment's client, a recognised leader in precision engineering and medical device manufacturing, seeks a Quality Leader to guide the Quality function and ensure site compliance with QSR, FDA, ISO, and business plans.

Reporting to the Quality Director, you will provide technical leadership, lead internal audits, CAPA actions, and drive continuous improvement using Minitab and data-driven decision-making.

Qualifications

  • Bachelor's degree in a scientific discipline (advantage).
  • Minimum 5 years of quality management experience in medical devices or FDA-regulated environments.
  • 3–5 years of people leadership experience; Lead Auditor certification preferred.

Responsabilités

  • Ensure QSR/ISO compliance and act as management representative.
  • Lead internal audits and CAPA processes; drive corrective actions.
  • Drive quality improvements via Lean initiatives and data analytics.
  • Interpret engineering drawings; support measurement/inspection processes.
  • Prepare daily management reports and identify improvement opportunities.

Connaissances

Regulatory & Quality Systems
Statistical & Analytical Skills
Quality Assurance Leadership

Formation

Bachelor's degree in a scientific discipline

Outils

Minitab

Description du poste

Harmonics Recruitment's client, a recognised leader in precision engineering and medical device manufacturing, seeks a Quality Leader to guide the Quality function and ensure site compliance with QSR, FDA, ISO, and business plans.

Reporting to the Quality Director, you will provide technical leadership, lead internal audits, CAPA actions, and drive continuous improvement using Minitab and data-driven decision-making.

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