Quality Engineer I, Post Market Surveillance (PMS) - Becton Dickinson

We Are The People Who Give Possibilities PurposeBD 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 manufacturing and marketing—to look at the impossible and find transformative solutions that turn dreams into possibilities.Job DescriptionResponsibilitiesWork 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 necessary for generating applicable reportsCoordinate and provide oversight in the analysis of PMS dataIdentify and elevate 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 fulfill ad‑hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including Master Control, JDEPerform other related duties and responsibilities as assignedAbility to travel up to 5% of the timeQualificationsRequired QualificationsApply project management tools to ensure reports are submitted based on the commitment timelinesAbility to make and present risk‑based decisionsStrong interpersonal skillsProblem solving abilityAbility to create, review, and coordinate reports based on established guidelines and regulatory requirementsOral and written presentation skillsAbility to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitmentsEducation and/or ExperienceRequires a minimum of a bachelor's degree, engineering degree, or degree in a technical fieldProficient in Windows OS and Microsoft Office SuiteProficient in Excel and data manipulationPreferred Knowledge and SkillsMedical device experience working with Class I, II, and III devicesExperience in technical writing and project managementAbility to develop and maintain dashboards using BI toolsPhysical DemandsWhile performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel, or crouch.Work EnvironmentWhile performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations. BD prioritizes on-site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Primary Work Location: USA AZ - Tempe HeadquartersWork Shift: PandoLogic.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.#J-18808-Ljbffr