NPI Quality Engineer III – Medical Device R&D & Validation

Mason Alexander; Wexford; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

Mason Alexander seeks an experienced NPI Quality Engineer to join the Design Assurance Team in Ireland. You will support product development from a quality perspective, working through PD phases, including test method development, IQ/OQ/PQ, DV testing and report writing.

As NPI Quality Engineer III, you will research and introduce new technologies and equipment, drive risk management per ISO14971, and lead continuous improvement projects for efficient NPI activities.

Formación

• Bachelor's degree in engineering or related field.
• At least 3 years in engineering within the medical device sector.
• Experience with R&D, product development or quality engineering.
• Experience with test method development and process validation is essential.
• Strong problem solving and communication skills.

Responsabilidades

• Support New Product Introduction with design, tooling, testing and fixtures.
• Test and validate new methods; perform gage R&R and statistical analysis (Minitab).
• Support site quality activities: internal audits, readiness, CAPAs and QMS.
• Assist risk management per ISO14971 and participate in planning.
• Lead continuous improvement projects.
• Stay updated on new technologies and equipment to enhance NPI quality.

Conocimientos

NPI quality engineering

Test method development

Process validation

Quality engineering

Project management

Communication skills

Minitab

Educación

Bachelor's degree in Engineering

Herramientas

Minitab

Descripción del empleo

Mason Alexander seeks an experienced NPI Quality Engineer to join the Design Assurance Team in Ireland. You will support product development from a quality perspective, working through PD phases, including test method development, IQ/OQ/PQ, DV testing and report writing.

As NPI Quality Engineer III, you will research and introduce new technologies and equipment, drive risk management per ISO14971, and lead continuous improvement projects for efficient NPI activities.