Job Title: Production Manager – Medical Devices
Location: Galway
Department: Manufacturing / Operations

The Production Manager is responsible for planning, coordinating, and controlling all manufacturing activities to ensure safe, compliant, efficient, and on‑time production of medical devices. The role ensures adherence to quality, regulatory, and H&S standards (ISO 13485, FDA, MDR where applicable) while driving continuous improvement, cost control, and team performance.

Key Responsibilities
Production Management & Planning

• Lead day‑to‑day production operations to meet output, quality, and delivery targets.
• Develop and manage production plans, schedules, and resource allocation (people, equipment, materials).
• Monitor line performance, yields, and OEE; implement corrective actions where targets are not met.
• Ensure effective coordination with Planning, Supply Chain, Quality, Engineering, and Maintenance.

• Manage and develop a team of Shift Leaders / Supervisors and Production Operators.
• Set clear objectives, KPIs, and performance standards; conduct regular performance reviews.
• Drive a culture of accountability, engagement, and continuous improvement on the shop floor.
• Lead recruitment, onboarding, skills development, and cross‑training of production staff.

• Ensure all production activities comply with ISO 13485, FDA QSR, EU MDR, GMP, and internal SOPs.
• Partner with Quality to investigate non‑conformances, deviations, and customer complaints and implement CAPAs.
• Ensure batch records, device history records (DHRs), and production documentation are completed accurately and on time.
• Support internal and external audits (notified body, FDA, corporate) from a production perspective.

• Ensure a safe working environment, adherence to H&S policies, and legal requirements.
• Drive safety culture and behavioural safety on the shop floor; lead incident investigations and corrective actions.

• Identify and deliver productivity, yield, and scrap‑reduction initiatives using Lean/6σ methodologies.
• Optimise labour, materials, and overhead usage to meet cost and efficiency targets.
• Support new product introductions (NPI) and process transfers into production, ensuring smooth ramp‑up.

• Provide daily/weekly/monthly production performance reports and KPI dashboards.
• Work closely with Planning, Supply Chain, Engineering, and Quality to resolve issues and support business objectives.

Education & Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Science, or related discipline (or equivalent experience).
• Further qualifications in Operations Management, Lean, or Six Sigma desirable (e.g., Green/Black Belt).

Experience

• 5+ years’ experience in a manufacturing environment, with at least 2–3 years in a supervisory/managerial role.
• Proven experience in the medical device, pharma, or other regulated life‑science manufacturing environment.
• Track record of managing production teams in a high‑volume or high‑mix, quality‑critical environment.
• Experience working under ISO 13485 and/or FDA QSR, with demonstrated involvement in audits and CAPAs.
• Strong understanding of GMP, ISO 13485, and regulatory expectations for medical device manufacturing.
• Good knowledge of Lean manufacturing tools (5S, value stream mapping, SMED, problem‑solving, etc.).
• Ability to interpret production data and KPIs; competent with MS Office and ERP/MES systems.
• Experience supporting NPIs and process validation (IQ/OQ/PQ) advantageous.
• Strong people leadership and team‑building skills.
• Decisive, with the ability to prioritise effectively in a fast‑paced environment.
• Excellent communication and influencing skills across all levels.
• Structured problem‑solver with a continuous improvement mindset.
• High level of integrity and commitment to compliance, quality, and safety.

KSGalway

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