QA Engineer
ICS Medical Devices · Galway, Connacht, Ireland
Medical Equipment Manufacturing · 51-200 employees
About the role
Maintain the Quality Management System and ensure compliance with regulatory and customer requirements across the product lifecycle. Lead quality activities from design controls and validation to final product release and supplier compliance.
What they look for
Requirements
Requires a degree in Quality, Science, or Engineering with over 4 years of experience in medical device design or manufacturing. Must possess strong knowledge of FDA and ISO 13485 standards and experience with statistical tools like Minitab.
Benefits
Full description
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 & Taxsaver 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.
