Design Quality Engineer
About Your New Employer
- Join a leading medical device organisation focused on innovative products for peripheral arterial and venous disease, cancer detection, and renal care.
- Be part of a company committed to rigorous quality standards and advancing healthcare technology.
- Work in a collaborative, highly regulated, and dynamic environment that supports professional growth and development.
About Your New Job
- As a Design Quality Engineer, you will ensure compliance with all relevant regulatory requirements and internal procedures.
- You will manage Quality Engineering resources for New Product Development (NPD) and New Product Introduction (NPI) initiatives.
- Provide expert Quality Engineering support for validation activities, reliability and statistical analysis, component and process qualifications, and equipment validations.
- Facilitate risk management processes, maintain risk files, and support post-market surveillance.
- Collaborate with R&D and Engineering to deliver robust product launches and lifecycle management.
- Review and approve validation documents, participate in audits, support regulatory activities, and drive a culture of quality and innovation.
What Skills You Need
- Third-level degree in Engineering, Science, or a related discipline.
- Minimum 3+ years’ experience in Class II or III medical devices.
- Experience in a regulated medical device, pharmaceutical, or life sciences environment.
- Strong knowledge of QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR, and ICH guidelines.
- Hands-on experience with design, process, equipment, and software validation.
- Proficiency with quality engineering tools: risk management, root cause analysis, statistics, and process capability.
- Demonstrated ability to drive results, manage complexity, prioritise effectively, and lead cross-functional teams.
What's on Offer
- Competitive salary and benefits package, offering clear progression routes within a growing organisation.
- Exposure to innovative projects, regulatory complexity, and multidisciplinary teamwork.
- Opportunities for learning, development, and continuous improvement in a supportive work culture.
What's Next
Apply now by clicking the “Apply Now” button. If you’d like to discuss the role in more detail, please get in touch by calling +353 214847136 – we’d love to hear from you. If this isn’t quite right but you’re interested in similar opportunities, reach out – we have various roles available.