Design Quality Engineer, Wexford

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.

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