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Production Manager – Medical Devices

Gi Group · Galway

🇬🇧 English
ISO 13485 FDA QSR EU MDR GMP Lean Six Sigma OEE device history records

Job description

About the role

The Production Manager will lead day‑to‑day manufacturing operations for a medical‑device facility in Galway. You will be accountable for meeting output, quality and delivery targets while ensuring compliance with regulatory standards.

Key responsibilities

  • Plan, schedule and allocate resources (people, equipment, materials) to achieve production targets.
  • Monitor line performance, yields and OEE; implement corrective actions when needed.
  • Coordinate with Planning, Supply Chain, Quality, Engineering and Maintenance.
  • Lead, coach and develop Shift Leaders, Supervisors and Operators; set KPIs and conduct performance reviews.
  • Ensure compliance with ISO 13485, FDA QSR, EU MDR, GMP and internal SOPs.
  • Partner with Quality to investigate non‑conformances, deviations and complaints; drive CAPA implementation.
  • Support internal and external audits from a production perspective.
  • Promote a safe working environment and lead incident investigations.
  • Identify productivity, yield and scrap‑reduction initiatives using Lean/6σ.
  • Optimize labour, material and overhead usage to meet cost targets.
  • Assist with new product introductions and process transfers.
  • Provide regular production performance reports and KPI dashboards.

Required profile

  • Bachelor’s degree in Engineering, Manufacturing, Science or related field (or equivalent experience).
  • 5+ years of manufacturing experience, including 2‑3 years in a supervisory/managerial role.
  • Experience in regulated life‑science environments (medical devices, pharma).
  • Demonstrated ability to manage high‑volume or high‑mix production teams.

Required skills

  • Knowledge of ISO 13485, FDA QSR, EU MDR and GMP requirements.
  • Lean and Six Sigma methodologies (Green/Black Belt preferred).
  • Understanding of OEE, batch record and device history record management.
  • Production planning and resource allocation.
  • KPI reporting and dashboard creation.

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Published 3 months ago

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Gi Group

Galway