Quality Engineer II - Medical Devices, Flexible Hours

Wallace Myers International; Galway; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Flexible benefits

Flexible hours

Generous leave

Training & development

Job summary

Wallace Myers International seeks a Quality Engineer II in Galway to support process quality and design assurance across development and manufacturing of patient-focused medical devices. You will collaborate with R&D, Regulatory and Manufacturing Engineering to ensure a smooth transition from design to production.

The role emphasizes DFMEA/PFMEA, equipment validation, and process optimisation in a fast-growing medical device environment.

Qualifications

• Engineering or technical qualification required; ASQ CQE preferred.
• ISO 13485 or regulated environment experience.
• Experience in design for manufacturability (DFM).
• Proven ability to transfer designs to manufacturing and perform DFMEA to PFMEA.
• Experience installing and validating equipment and processes.
• Strong problem-solving and root-cause investigation skills.
• Proficient with statistics, MS Excel and Word.
• Lead Auditor certification desirable.

Responsibilities

• Support transfer of design activities into manufacturing.
• Support design verification and validation testing and test methods.
• Plan and support product builds for R&D testing and clinical trials.
• Lead transfer of electromechanical device assembly line with Project Manager and Quality Director.
• Support equipment, process and test method validation activities.
• Collaborate with external manufacturing partners and suppliers.
• Identify opportunities for process optimisation and manufacturability.

Skills

Root-cause investigation

Statistical tools

Process improvement

Communication skills

Training colleagues

Education

Engineering qualification (incl. ASQ CQE)

Tools

MS Excel

MS Word

Test equipment validation

PCB/electromechanical knowledge

Job description

Wallace Myers International seeks a Quality Engineer II in Galway to support process quality and design assurance across development and manufacturing of patient-focused medical devices. You will collaborate with R&D, Regulatory and Manufacturing Engineering to ensure a smooth transition from design to production.

The role emphasizes DFMEA/PFMEA, equipment validation, and process optimisation in a fast-growing medical device environment.