Quality Engineer

ICS Medical Devices; Galway; Sur place; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Bonus

Private medical insurance

Additional holidays

Sick pay

Pension plan

Sports club

Cycle to work

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Formation

Degree in Quality, Science, or Engineering

Outils

Minitab

MS Office

Description du poste

Join our growing Quality team and play a key role in ensuring compliance, performance, and continuous improvement across our medical device operations.

About The Role

As a Quality Engineer, you will support the maintenance and development of our Quality Management System, ensuring compliance with customer, regulatory, and internal requirements. You’ll work across the full product lifecycle—from concept through to production—contributing to high-quality outcomes across multiple production lines.

This is a dynamic role where you’ll manage multiple projects, collaborate cross-functionally, and apply strong communication and problem-solving skills to drive quality excellence.

Key Responsibilities

• 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

What We’re Looking For

• Degree in Quality, Science, or Engineering
• 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

Desirable

• Experience in new product introduction (NPI) and process transfer
• Knowledge of medical device standards and regulatory requirements

Benefits

• Competitive Salary Bonus
• Private medical insurance
• Additional Holidays
• Sick pay
• Occupational Pension Plan
• Sports Social Club
• Cycle to Work Tax saver Commuter Ticket Scheme

If you’re passionate about quality, innovation, and making an impact in the medical device industry, we’d love to hear from you.