Lead Quality Engineer, Medical Devices & Process Optimization

Edwards; Limerick; Hybrid; EUR 75,000 - 95,000; Full time

Job summary

Edwards in Ireland is seeking a Senior Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimization of product development, internal and external device manufacturing, and distribution.

You will lead investigations into quality issues, train staff, supervise tests, and drive process improvements using Six Sigma and LEAN principles across multiple teams. Strong documentation and communication skills are essential.

Qualifications

• Bachelor's degree in engineering or a scientific field.
• Minimum of 6 years experience in quality engineering.
• Ability to read and interpret drawings.
• Strong knowledge of Six Sigma concepts and quality systems.
• Excellent documentation and communication skills.
• Strong leadership and collaboration across teams.

Responsibilities

• Lead investigation of complex manufacturing quality and compliance issues (CAPA, non-conformances, audit observations) for all production processes.
• Train and guide lower level employees on complex procedures and direct project activities.
• Oversee quality support tasks and supervise engineers/technicians delivering tests and feedback.
• Drive development and execution of experiments and tests to create, validate, and improve products and processes.
• Identify and optimize complex manufacturing processes using Six Sigma and LEAN methods.
• Oversee risk management content and ensure alignment with global procedures; define validation strategies.
• Develop training and production work instructions for knowledge transfer.
• Adhere to Edwards EH&S and Quality guidelines in clean room manufacturing.
• Interact professionally with all organizational levels and external customers.

Skills

MS Office

Reading drawings

Statistical methods

Documentation skills

Leadership

Six Sigma

Quality engineering

Cross-functional fit

Education

Bachelor's Degree in Engineering or Scientific field

Job description

Edwards in Ireland is seeking a Senior Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimization of product development, internal and external device manufacturing, and distribution.

You will lead investigations into quality issues, train staff, supervise tests, and drive process improvements using Six Sigma and LEAN principles across multiple teams. Strong documentation and communication skills are essential.