Quality Engineer II, Post Market Surveillance

Job Description Summary The 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 Description We 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 Responsibilities Work with a team to meet the requirements in generating periodic PMS related reports Identify development and training opportunities for PMS team along with Manager Participate in projects to align with BDX Quality, MDD/MDR strategies and regulatory submissions Identify gaps and maintain PMS processes in compliance with global regulations Participate in PMS planning and reporting Extract and generate PMS and operational performance data necessary for generating applicable reports. Analyze and interpret PMS data Identify and elevate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity Identify and evaluate new failure modes when encountered Maintain procedures, as necessary Support responding to requests for additional information from competent authorities, registries and notified body Working cross-functionally with Quality, Regulatory, Clinical Affair and Operations departments to fulfill ad‑hoc data requests and deliver detailed analysis of PMS data Develop and maintain knowledge of support systems including MasterControl, JDE, Global Complaint System (GCS) and Power BI Tool Kit Performs other related duties and responsibilities as assigned Ability to travel up to 5% of the time Education And Experience Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field Minimum of four years’ experience in engineering or quality engineering experience within the medical device, pharmaceutical, or equivalent industry Knowledge And Skills Required Qualifications Medical device experience working with Class I, II, and III devices Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to develop solutions with business impact Working knowledge of statistical and risk assessment techniques Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to create and provide training Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to lead cross functional teams Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments Understanding of regulatory requirements including ISO 13485, ISO 14971 Proficient in Windows OS, Microsoft Office Suite particularly PowerPoint Proficient in Excel in manipulation of data using pivot tables, VLOOKUP, conditional formatting, formulas, and macros Preferred Qualifications SQL database or equivalent data warehouse experience and associated validation activities Ability to develop & maintain dashboards using BI tools such as Power BI, QlikView, Tableau, Looker, Alteryx or equivalent Physical Demands While 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. 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 Equal Opportunity Employer Statement 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. Primary Work Location: USA AZ - Tempe Headquarters #J-18808-Ljbffr BD