Staff Quality Engineer (Post Market)

Job Description Senior Quality Engineer – Works in design control, risk management, and post‑market activities to support BD’s medical device portfolio. Responsibilities Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements. Engage in design, development, and post‑market activities for both medical and non‑medical products. Ensure harmonization of risk‑management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members. Oversee risk management using ISO 14971 standards to ensure product safety, define critical quality attributes, assess residual risks, and present risk/benefit justifications to executive leadership. Perform and document Risk Reviews to communicate results of the risk‑management process to cross‑functional teams. Identify opportunities for continuous improvement of the risk‑management process. Required Qualifications Bachelor’s degree in engineering or related field and 5years of quality, design controls, risk management experience within the medical device industry. Minimum of 5years of post‑market quality experience, including complaint trending/data analytics. Advanced knowledge of risk management, design controls, regulatory, quality‑engineering policies, principles, and standard methodologies. Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971 and ISO 13485. Strong oral and written communication, interpersonal skills, technical problem‑solving, teamwork, critical thinking, and adaptability in a rapidly changing environment. Preferred Qualifications Experience with hazard analysis or FMEA and verification/validation. Relevant quality certifications such as ASQ Certified Quality Engineer, Certified Auditor, and Six Sigma credentials. Benefits Competitive salary range: $124,700.00 – $205,800.00USD annually. Culture of collaboration, learning, and innovation with performance‑based recognition and comprehensive total‑rewards program. Equal Opportunity Employer 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 Becton Dickinson