Quality Engineer II, Post Market Surveillance

Job Description SummaryThe Quality Engineer II supports Post Market Surveillance activities through the collection, analysis, trending, and reporting on safety data to proactively identify potential adverse safety risks or performance trends. The incumbent 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. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended to be inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.Job DescriptionWe are the makers of possible. BD 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.Job ResponsibilitiesWork with a team to meet the requirements in generating periodic PMS related reportsIdentify development and training opportunities for PMS team along with ManagerParticipate in projects to align with BDX 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.Analyze and interpret 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 bodyWorking cross-functionally with Quality, Regulatory, Clinical Affair and Operations departments to fulfill ad‑hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including MasterControl, JDE, Global Complaint System (GCS) and Power BI Tool KitPerforms other related duties and responsibilities as assignedAbility to travel up to 5% of the timeEducation And ExperienceRequires a minimum of a bachelor's degree, Engineering Degree, or degree in a technical fieldMinimum of four years' experience in engineering or quality engineering experience within the medical device, pharmaceutical, or equivalent industryKnowledge And SkillsRequired QualificationsMedical device experience working with Class I, II, and III devicesApply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Ability to develop solutions with business impactWorking knowledge of statistical and risk assessment techniquesWorking knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologiesAbility to make and present risk-based decisionsStrong interpersonal skillsAbility to create and provide trainingProblem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to lead cross functional teamsAbility to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitmentsUnderstanding of regulatory requirements including ISO 13485, ISO 14971Proficient in Windows OS, Microsoft Office Suite particularly PowerPointProficient in Excel in manipulation of data using pivot tables, VLOOKUP, conditional formatting, formulas, and macrosPreferred QualificationsSQL database or equivalent data warehouse experience and associated validation activitiesAbility to develop & maintain dashboards using BI tools such as Power BI, QlikView, Tableau, Looker, Alteryx or equivalentPhysical 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.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.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.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.To learn more about BD visit Opportunity Employer StatementBecton, 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.Primary Work Location: USA AZ - Tempe Headquarters#J-18808-Ljbffr