Quality Engineering Lead - Medical Devices & Compliance

Edwards Lifesciences; Limerick; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Engineering Manager to lead a sustaining and transfer-focused team. The role involves coaching engineers, representing QA in cross-functional programs, and driving NCR/CAPA activities to meet product quality requirements.

You will oversee training, audits, and continuous improvement initiatives within a regulated medical device environment, ensuring compliant quality systems and timely project execution.

Qualifications

• Bachelor's Degree in Science or Engineering is required.
• Experience in a regulated medical device environment is required.
• Strong leadership and coaching skills are essential.

Responsibilities

• Lead a Quality Engineering team in Sustaining and Transfer projects.
• Coach and mentor Quality Engineers in day-to-day activities.
• Represent Quality Engineering in tiered and core cross-functional teams.
• Drive on-time delivery of project and sustaining deliverables.
• Lead NCR and CAPA activities and drive continuous improvement.
• Ensure staff training and adherence to quality systems and procedures.
• Support audits and coordinate resource needs for project transfers.

Skills

Leadership

Quality mindset

Analytical thinking

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor's Degree in Science or Engineering

Job description

Edwards Lifesciences is seeking a Quality Engineering Manager to lead a sustaining and transfer-focused team. The role involves coaching engineers, representing QA in cross-functional programs, and driving NCR/CAPA activities to meet product quality requirements.

You will oversee training, audits, and continuous improvement initiatives within a regulated medical device environment, ensuring compliant quality systems and timely project execution.