Quality Engineer II

Wallace Myers International; Galway; Presencial; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible benefits

Flexible hours

Generous leave

Training & development

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Root-cause investigation

Statistical tools

Process improvement

Communication skills

Training colleagues

Educación

Engineering qualification (incl. ASQ CQE)

Herramientas

MS Excel

MS Word

Test equipment validation

PCB/electromechanical knowledge

Descripción del empleo

An innovative, growing medical device company in Galway is seeking a Quality Engineer II to support process quality and design assurance across the development and manufacture of patient-focused medical devices. Working closely with R&D, Clinical, Regulatory and Manufacturing Engineering teams, you will help ensure a robust transition from design through to production. The seniority of the position may be tailored to the successful candidate's experience.

Key Responsibilities

• Support the transfer of design activities into manufacturing, including dFMEA to pFMEA, design specifications to manufacturing specifications, and design test methods to process test methods.
• Support design verification and validation testing, including associated test methods.
• Plan and support product builds for R&D testing, product verification, clinical trials and commercial use alongside R&D colleagues.
• Lead the transfer of an electromechanical medical device assembly line, supported by the Project Manager and Quality Director.
• Support equipment, process and test method validation activities.
• Collaborate with external manufacturing partners and suppliers.
• Identify and implement opportunities for process optimisation and improved manufacturability.
• Engineering, scientific or technical qualification (including ASQ CQE).
• At least 3 years of engineering experience in a manufacturing environment.
• Experience working within an ISO 13485 quality management system or equivalent regulated environment.
• Experience improving processes with design for manufacturability (DFM) considerations.
• Experience installing and validating equipment, processes or test methods.
• Strong problem-solving and root-cause investigation skills.
• Ability to use statistical tools and proficiency with MS Excel and Word.
• Strong communication skills and confidence engaging with internal and external stakeholders.
• Lead Auditor certification.
• Experience with PCBs, electrical components, electromechanical assemblies or polymeric components.
• Process validation and assembly line transfer experience.
• Experience in a start-up or SME environment.
• Experience training or developing colleagues.

What's on Offer

A competitive salary and flexible benefits package, flexible working hours, generous annual leave, and opportunities for training and professional development in a collaborative, fast-moving medical device environment.