Job DescriptionWe are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.About the roleThis role supports the Design Quality team in Enniscorthy, with the 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 BD procedures, and plays a key role in planning, developing, implementing, and ongoing support of projects, aligning quality objectives with site and organisational goals.Main responsibilitiesEnsure compliance with all applicable regulatory requirements, standards, and BD proceduresManage and allocate Quality Engineering resources for New Product Development (NPD) and New Product Introduction (NPI) programsProvide Quality Engineering support for test method validation, product verification and validation, reliability testing, and statistical data analysisOversee component qualifications, process capability studies, equipment qualifications, and process validationsFacilitate and ensure compliance with risk management activities, supporting NPD/NPI teams in generating and maintaining risk filesSupport field assurance investigations and post‑market surveillance activities as requiredCollaborate closely with R&D and Engineering to enable successful execution of the product development lifecycle and robust product launchesReview and approve validation documentation and risk management files; participate in regulatory, corporate, and third‑party auditsSupport regulatory submissions, promote a positive teamwork culture, and contribute to additional projects as assignedRequired QualificationsThird‑level degree in Engineering, Science, or a related technical disciplineMinimum of 3+ years’ experience in Class II or Class III medical devices; experience working in a highly regulated environment (medical device, pharmaceutical, or life sciences)Experience & Technical ExpertiseStrong knowledge of quality and regulatory standards, including QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR, and applicable ICH guidelinesHands‑on experience with design, process, equipment, test method, and software validation activitiesProficiency in Quality Engineering tools such as risk management, root cause analysis, statistics, sampling plans, and process capability studiesExperience supporting new product development and commercialization, including risk assessments and component qualificationProven experience conducting and supporting quality and regulatory auditsSkills & CompetenciesDemonstrated ability to drive results, take ownership, and deliver high‑quality outcomes in a fast‑paced environmentAction‑oriented mindset with the confidence to make decisions amid complexity and ambiguityStrong customer focus, with the ability to build trusted relationships across internal and external stakeholdersExcellent communication, presentation, and influencing skills at all organisational levelsCollaborative team leader who promotes engagement, accountability, and continuous learningStrong analytical and problem‑solving capabilities, with the ability to effectively prioritize and manage multiple demandsAdaptable, self‑motivated, and open to innovation and continuous improvementSalary Range€50K - €55KEqual Opportunity EmployerBecton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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