Quality Engineer I, Post Market Surveillance (PMS)

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 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. Job DescriptionRESPONSIBILITIES Responsibilities include, however are not limited to: Work with a team to meet the requirements in generating periodic PMS related reports Participate 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 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 fulfill ad-hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including Master Control, JDEPerforms 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 field Proficient in Windows OS, Microsoft Office SuiteProficient in Excel in manipulation of dataPreferred Knowledge and Skills Medical device experience working with Class l, ll, and lll devicesExperience in technical writing and project managementAbility to develop & 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 Environment:While 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.At BD, we prioritize 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.#CLOLIWhy Join Us?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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit.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.Required SkillsOptional Skills.Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork ShiftSummaryLocation: USA AZ - Tempe HeadquartersType: Full time