Senior Design Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Galway, Ireland Job Description: We are searching for the best talent for a  Senior Design Quality Engineer . Purpose We are looking for a Senior Design Quality Engineer to join our team. In this role, we provide design quality and compliance expertise to support the development of new products and improvements to existing products. We work closely with cross‑functional teams to ensure customer needs are met while maintaining compliance with applicable regulations and company requirements. This role plays a key part in design control, risk management, and quality system activities across the product lifecycle, including development, manufacturing, and post‑market support. You will be responsible for Ensuring Design Control and Risk Management activities comply with applicable processes and regulatory requirements Acting as a Design Quality team member supporting new product development and lifecycle management activities Providing guidance on medical device regulations and design control requirements across global markets Supporting product development teams in the effective application of design controls and risk management principles Partnering with design teams to define design inputs and outputs, support verification and validation activities, and contribute to process validation, design transfer, and launch planning Ensuring critical‑to‑quality requirements are identified and translated into design and process specifications Supporting and developing risk management activities, including identification of risks and implementation of control measures Managing and delivering quality outputs for R&D projects Providing guidance and support to Design Quality Engineers and Quality Engineers Coordinating Design Quality resources to support business priorities, where needed Engaging with cross‑functional partners to resolve issues and drive alignment Applying structured problem‑solving approaches to identify, communicate, and resolve quality issues Supporting design reviews and maintaining accurate design control records Reviewing and approving R&D and production batch documentation, including sterilization records, to support timely project progression Supporting bench testing activities as required Monitoring Quality Management System data and identifying trends or issues Leading or supporting quality system improvement activities, including CAPA and nonconformance management Supporting internal and supplier audits and participating in inspections as needed Collaborating with Regulatory Affairs on submissions and deliverables Supporting complaint investigations, escalation activities, and post‑launch CAPA where required Delivering quality system training and promoting quality awareness across the organization Ensuring compliance with all applicable regulations, policies, and procedures Qualifications / Requirements Degree in an engineering or technical discipline Minimum 5 years of experience in the medical device, IVD, or pharmaceutical industry Experience working with Quality