Quality Engineer, Medical Devices: Drive Compliance & Improvement

ICS Medical Devices; Galway; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive Salary & Bonus

Private medical insurance

Additional Holidays

Sick pay

Occupational Pension Plan

Sports & Social Club

Cycle to Work

Tax saver Commuter Ticket Scheme

Job summary

ICS Medical Devices in Ireland is seeking a Quality Engineer to maintain and enhance our Quality Management System across product lifecycle. You will ensure compliance with FDA/ISO 13485, lead quality activities from incoming inspection to final release, and collaborate with design and manufacturing teams to drive quality improvements.

The role requires a degree in Quality, Science or Engineering and at least 4 years in medical device design or manufacturing, with strong communication skills and

Qualifications

• :Degree in Quality, Science, or Engineering.
• :Experience in a medical device design or manufacturing environment (4+ years).
• :Knowledge of FDA & ISO 13485 quality systems.
• :Experience with design assurance, validation, and manufacturing processes.
• :Familiarity with statistical tools (e.g., Minitab) and MS Office.
• :Excellent communication and stakeholder management skills.

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

Skills

Quality Engineering

Regulatory knowledge (FDA/ISO13485)

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Quality/Engineering/Science

Tools

Minitab

Microsoft Office

Job description

ICS Medical Devices in Ireland is seeking a Quality Engineer to maintain and enhance our Quality Management System across product lifecycle. You will ensure compliance with FDA/ISO 13485, lead quality activities from incoming inspection to final release, and collaborate with design and manufacturing teams to drive quality improvements.

The role requires a degree in Quality, Science or Engineering and at least 4 years in medical device design or manufacturing, with strong communication skills and