Quality Engineer, Med Devices – ISO 13485 & NPI

ICS Medical Devices; Galway; In loco; EUR 70.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Bonus

Private medical insurance

Additional holidays

Sick pay

Pension plan

Sports club

Cycle to work

Descrizione del lavoro

ICS Medical Devices is seeking a Quality Engineer to support the maintenance and development of our Quality Management System across the full product lifecycle. You will collaborate with design, engineering, and manufacturing teams to ensure compliance with FDA/ISO 13485 standards and drive quality improvements.

The role emphasizes problem-solving, data-driven decision making, and strong stakeholder communication.

Competenze

• 4+ years’ experience in a medical device design or manufacturing environment.
• Strong knowledge of FDA ISO 13485 quality systems.
• Experience with design assurance, validation, and manufacturing processes.
• Familiarity with statistical tools (e.g., Minitab) and Microsoft Office suite.
• Excellent communication and stakeholder management skills.

Mansioni

• Maintain quality system metrics and support validation, production, and change control activities.
• Partner with design and engineering teams on product development and design controls.
• Support risk management, design assurance, and design verification validation activities.
• Develop test methods, validation plans, protocols, and reports.
• Contribute to design reviews and maintain Design History Files.
• Support audits (internal, regulatory, and customer).
• Lead quality activities from incoming inspection to final product release.
• Provide manufacturing support and quality expertise for product disposition.
• Drive continuous improvement and promote a strong quality culture.
• Work with suppliers to ensure compliance with quality standards.

Formazione

Degree in Quality, Science, or Engineering

Strumenti

Minitab

MS Office

Descrizione del lavoro

ICS Medical Devices is seeking a Quality Engineer to support the maintenance and development of our Quality Management System across the full product lifecycle. You will collaborate with design, engineering, and manufacturing teams to ensure compliance with FDA/ISO 13485 standards and drive quality improvements.

The role emphasizes problem-solving, data-driven decision making, and strong stakeholder communication.