Design Quality Lead - County Wexford

Design Quality Lead - County Wexford.

This position is being offered as a fixed-term contract.

This role leads the Design Quality team, with primary responsibility for developing, maintaining, and governing the product risk management file, while providing comprehensive quality engineering support across new product development and product introduction activities. The position ensures full compliance with applicable regulatory requirements and company procedures, and plays a key role in the planning, development, implementation, and ongoing support of projects, aligning quality objectives with site and organisational goals.

Main responsibilities will include:
• Lead and manage Quality Engineering direct reports, including hiring, performance management, training, development, and corrective actions
• Ensure compliance with all applicable regulatory requirements, standards, and procedures
• Manage and allocate Quality Engineering resources for New Product Development (NPD) and New Product Introduction (NPI) programs
• Provide Quality Engineering support for test method validation, product verification and validation, reliability testing, and statistical data analysis
• Oversee component qualifications, process capability studies, equipment qualifications, and process validations
• Facilitate and ensure compliance with risk management activities, supporting NPD/NPI teams in generating and maintaining risk files
• Support field assurance investigations and post-market surveillance activities as required
• Collaborate closely with R&D and Engineering to enable successful execution of the product development lifecycle and robust product launches
• Review and approve validation documentation and risk management files; participate in regulatory, corporate, and third-party audits
• Support regulatory submissions, promote a positive teamwork culture, and contribute to additional projects as assigned

Interested applicants should have:
• Third level degree in Engineering, Science, or a related technical discipline
• Minimum 5 years’ experience in Class II or Class III medical devices, with at least 3 years in a people management or supervisory role
• Experience working in a highly regulated environment (medical device, pharmaceutical, or life sciences)
• Strong knowledge of quality and regulatory standards, including QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR, and applicable ICH guidelines
• Hands-on experience with design, process, equipment, test method, and software validation activities
• Proficiency in Quality Engineering tools such as risk management, root cause analysis, statistics, sampling plans, and process capability studies
• Experience supporting new product development and commercialisation, including risk assessments and component qualification
• Proven experience conducting and supporting quality and regulatory audits

• Demonstrated ability to drive results, take ownership, and deliver high quality outcomes in a fast-paced environment
• Action oriented mindset with the confidence to make decisions amid complexity and ambiguity
• Strong customer focus, with the ability to build trusted relationships across internal and external stakeholders
• Excellent communication, presentation, and influencing skills at all organisational levels
• Collaborative team leader who promotes engagement, accountability, and continuous learning
• Strong analytical and problem-solving capabilities, with the ability to effectively prioritise and manage multiple demands
• Adaptable, self-motivated, and open to innovation and continuous improvement