Job Description
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world.
Advancing the world of healthTM 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 role
This 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 responsibilities
Ensure compliance with all applicable regulatory requirements, standards, and BD 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
Required Qualifications
Third-level degree in Engineering, Science, or a related technical discipline
Minimum 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 Expertise
Strong knowledge of quality and regulatory standards, including QSR, ISO *****, ISO *****, 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 commercialization, including risk assessments and component qualification
Proven experience conducting and supporting quality and regulatory audits
Skills & Competencies
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 prioritize and manage multiple demands
Adaptable, self-motivated, and open to innovation and continuous improvement
Salary Range
€50K - €55K
Equal Opportunity Employer
Becton, 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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