Design Quality Engineer

IrishJobs

Wexford, Wexford, Ireland

Wexford, Wexford, Ireland

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À propos

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,youwill ensure compliance with all relevant regulatory requirements and internal procedures. Youwill 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 youd like to discuss the role in more detail, please get in touch by calling wed love to hear from you. If this isnt quite right but youre interested in similar opportunities, reach out we have various roles available. Skills: machine design medical device Engineering Quality Benefits: See Description

TLNT1_IJ

Wexford, Wexford, Ireland

Compétences linguistiques

English

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