Quality Engineer, Medical Devices — Hybrid & Share Options

Life Science Recruitment Ltd; Galway; Hybrid; EUR 55,000 - 70,000; Full time

Benefits offered by this job

Salary

share options

pension

hybrid working

healthcare

Job summary

Life Science Recruitment Ltd is recruiting a Quality Engineer for a Galway-based Medical Device company. You will support quality systems, supplier quality and manufacturing with a focus on continuous improvement of products and processes.

You will lead quality activities with outsourced manufacturers, drive risk management and product transfer quality, and ensure regulatory compliance under MDR, FDA QSR and ISO 13485.

Qualifications

• Bachelor's degree or higher in Engineering/Science.
• 2+ years quality or manufacturing in medical devices.
• Knowledge of GMP per US/EU regulations for medical devices.
• Knowledge of ISO 14971 Risk Management applied to QMS.
• Ability to make decisions to sustain supply while maintain compliance.

Responsibilities

• Maintain and improve Quality Management System in line with MDR EU 2017/745, 21 CFR 820 and ISO 13485.
• Lead quality activities with outsourced manufacturers and suppliers for compliance.
• Lead risk management activities including FMEA.
• Drive risk-based problem solving to assure product quality and patient safety.
• Collaborate with cross‑functional engineering to deliver product transfer quality deliverables.
• Oversee process verification/validation per QMS policies.
• Own non-conformances and CAPAs, ensure containment, root cause analysis and corrective actions.

Skills

Quality systems

Risk management

CAPA management

Regulatory compliance

Cross-functional teamwork

Education

Engineering or Science degree

Job description

Life Science Recruitment Ltd is recruiting a Quality Engineer for a Galway-based Medical Device company. You will support quality systems, supplier quality and manufacturing with a focus on continuous improvement of products and processes.

You will lead quality activities with outsourced manufacturers, drive risk management and product transfer quality, and ensure regulatory compliance under MDR, FDA QSR and ISO 13485.