Job Description SummaryWe are looking for a Quality Engineer I, for our facility in BD Enniscorthy. You will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends.As the successful candidate, you will collaborate with cross-functional team members to ensure compliance with the applicable regulations, standards, and company policies/procedures.This position plays an integral role in maintaining compliance with global regulations. You will also work closely with the different functions onsite and between sites.Job DescriptionWe are the makers of possibleBD 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.Why join us?A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.Become a maker of possible with us!Our vision for Peripheral Intervention at BDOur Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.About the role We are looking for a Quality Engineer I, for our facility in BD Enniscorthy. You will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends.As the successful candidate, you will collaborate with cross functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures.This position plays an integral role in maintaining compliance with global regulations. You will also work closely with the different functions onsite and between sites.Main responsibilities will include:Work with a team to meet the requirements in generating periodic PMS related reportsParticipate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissionsIdentify gaps and maintain PMS processes in compliance with global regulationsParticipate in PMS planning and reportingExtract and generate PMS and operational performance data vital for generating applicable reports.Coordinate and provide oversight in the analysis of PMS dataIdentify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severityIdentify and evaluate new failure modes when encounteredMaintain procedures, as necessarySupport responding to requests for additional information from competent authorities, registries and notified bodiesWork cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfil ad-hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including Master ControlPerforms other related duties and responsibilities as assignedAbout you:Bachelor’s degree, Engineering Degree, or degree in a technical field is a minimum requirement.Proficient in Windows OS, Microsoft Office SuiteProficient in Excel in manipulation of dataStrong interpersonal skills with the ability to work in a team environment and work under own initiativeAbility to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitmentsProblem solving techniques with excellent organisational skills and attention to detailDedication to excellence, flexibility and adaptability to change.Preferred Knowledge and Skills Medical device experience working with Class l, ll, and lll devicesFamiliarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDRAbility to develop & maintain dashboards using BI toolsAbility to make and present risk-based decisionsExperience in technical writing and project managementOral and written presentation skillsAbility to create, review and coordinate reports based on established guidelines and regulatoryClick on apply if this sounds like you!Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.To learn more about BD visit: https://bd.com/careersRequired SkillsOptional Skills.Primary Work LocationIRL Wexford - EnniscorthyAdditional LocationsWork Shift