Quality Engineering Leader – Medical Devices & Manufacturing

Edwards Lifesciences; Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

Edwards Lifesciences in Limerick, Ireland seeks a Senior Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimized product development, manufacturing, and distribution.

You will lead investigations into complex quality issues, guide teams, and drive process improvements using Six Sigma and LEAN methodologies. A strong CQE background, data analysis, and effective communication are essential.

Qualifications

• Bachelor’s degree in Engineering or a Scientific field is required.
• Strong knowledge of quality systems, CQE concepts, and Six Sigma.
• Proven ability to analyze complex data, write reports, and communicate results clearly.

Responsibilities

• Lead investigation of manufacturing quality and compliance issues (CAPA, non-conformances, audits) across production processes.
• Train, coach, and guide lower-level staff on complex procedures and project activities.
• Oversee quality support tasks; instruct engineers/technicians on tests and provide feedback.
• Drive development and execution of complex experiments and tests, write protocols, and evaluate results.
• Lead identification and optimization of manufacturing processes using Six Sigma and LEAN methods.
• Oversee and align risk management files with global procedures; define validation strategies.
• Develop training and production documentation to enable knowledge transfer.
• Perform other incidental duties as required.

Skills

MS Office Suite

Reading drawings

Statistical techniques

Documentation & communication

Technical translation

CQE knowledge

Six Sigma

Quality engineering

Problem solving

Leadership

Education

Bachelor's degree in Engineering or sciences

Job description

Edwards Lifesciences in Limerick, Ireland seeks a Senior Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimized product development, manufacturing, and distribution.

You will lead investigations into complex quality issues, guide teams, and drive process improvements using Six Sigma and LEAN methodologies. A strong CQE background, data analysis, and effective communication are essential.