Senior Quality Engineer: Lead Manufacturing & Compliance

Edwards Lifesciences; Ireland; On-site; EUR 75,000 - 110,000; Full time

Job summary

Edwards Lifesciences in Ireland seeks an experienced Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimize product development, internal and external manufacturing, and device distribution.

You will lead investigations into complex manufacturing quality issues (CAPA, non-conformances, audits), train engineers and technicians, drive Six Sigma and LEAN improvements, develop protocols and risk management strategies, and prepare clear documentation and work

Qualifications

• Bachelor's Degree in Engineering or Scientific field.
• Minimum of 6 years experience.
• Excellent documentation and communication skills.
• Ability to read and interpret drawings.
• Knowledge of Six Sigma concepts.
• Knowledge of Quality Engineering concepts.

Responsibilities

• Lead investigation of manufacturing quality issues (CAPA, non-conformances, audits).
• Train engineers and technicians on complex procedures and project activities.
• Oversee quality support tasks and coordinate engineering work.
• Develop and execute complex experiments and tests to improve products and processes.
• Lead manufacturing process optimization using Six Sigma and LEAN methods.
• Define validation and risk management strategies and ensure implementation.
• Create training and production documentation to enable knowledge transfer.

Skills

Six Sigma

LEAN methods

Statistical techniques

Quality engineering concepts

Leadership skills

Problem solving

Interpersonal skills

Communication skills

Education

Bachelor's Degree in Engineering or Scientific field

Tools

MS Office Suite

Job description

Edwards Lifesciences in Ireland seeks an experienced Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimize product development, internal and external manufacturing, and device distribution.

You will lead investigations into complex manufacturing quality issues (CAPA, non-conformances, audits), train engineers and technicians, drive Six Sigma and LEAN improvements, develop protocols and risk management strategies, and prepare clear documentation and work