This role supports the Design Quality team at BD Enniscorthy, 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.
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.
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 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 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 organizational 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 €50,000 – €55,000.
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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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